Kit, Test, Pregnancy, Hcg, Over The Counter
FDA product code LCX · Class II (moderate risk) · 21 CFR 862.1155 · Clinical Chemistry
226510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Unipath , Ltd. 20
- ACON Laboratories, Inc. 10
- Armkel, LLC 10
- Quidel Corp. 9
- Syntron Bioresearch, Inc. 6
- Advanced Care Products 5
- Mizuho USA, Inc. 5
- Phamatech 5
- Vanguard Biomedical Corp. 4
- Spd Swiss Precision Diagnostics GmbH 4
- Church & Dwight Co., Inc. 4
- Abbott Laboratories 4
- Sa Scientific, Inc. 4
- Guangzhou Decheng Biotechnology Co., Ltd. 4
- Runbio Biotech Co.,Ltd 3
- Excel Scientific, Inc. 3
- Wyntek Diagnostics, Inc. 3
- Healthcheck Corp. 3
- Guangzhou Wondfo Biotech Co., Ltd. 3
- Cambridge Diagnostics Ireland, Ltd. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 09/09/2025SE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 07/15/2025SE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional | Assure Tech., LLC | 02/13/2025SE |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…LCX · Traditional | Nanjing Synthgene Medical Technology Co., Ltd. | 01/31/2025SE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | Assure Tech., LLC | 01/15/2025SE |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional | Andon Health Co, Ltd. | 12/20/2024SE |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…LCX · Traditional | Anhui Deepblue Medical Technology Co., Ltd. | 10/11/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 08/13/2024SE |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 06/21/2024SE |
| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 05/31/2024SE |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One…LCX · Traditional | Hangzhou Aichek Medical Technology Co., Ltd. | 04/12/2024SE |
| K234152 | ACESO Early Pregnancy TestLCX · Traditional | Aceso Laboratories, Inc. | 04/05/2024SE |
| K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test MidstreamLCX · Traditional | Assure Tech. (Hangzhou) Co, Ltd. | 02/05/2024SE |
| K240025 | Clearblue® Early Detection Pregnancy TestLCX · Special | Spd Swiss Precision Diagnostics GmbH | 01/31/2024SE |
| K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream IILCX · Traditional | Nantong Egens Biotechnology Co., Ltd. | 01/26/2024SE |
| K230741 | Macro & Micro-Test HCG Pregnancy Test MidstreamLCX · Traditional | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 10/13/2023SE |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 02/28/2023SE |
| K222305 | MissLan Digital Pregnancy Rapid TestLCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 11/30/2022SE |
| K213379 | Clearblue ® Early Pregnancy TestLCX · Traditional | Spd Swiss Precision Diagnostics GmbH | 09/21/2022SE |
| K212418 | hCG One Step Pregnancy TestLCX · Traditional | Healstone Biotech, Inc. | 06/30/2022SE |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One…LCX · Special | Co-Innovation Biotech Co., Ltd. | 04/05/2022SE |
| K210341 | One Step Pregnancy TestLCX · Traditional | Spd Swiss Precision Diagnostics GmbH | 03/10/2022SE |
| K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette…LCX · Traditional | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | 02/18/2022SE |
| K200913 | Clearblue® Early Digital Pregnancy TestLCX · Traditional | Spd Swiss Precision Diagnostics GmbH | 08/13/2021SE |
| K203246 | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test…LCX · Traditional | Atlas Link Technology Co., Ltd. | 08/04/2021SE |
| K193318 | Distinct® Early Detection Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 08/20/2020SE |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamLCX · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 08/13/2020SE |
| K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip…LCX · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 12/11/2019SE |
| K192843 | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette…LCX · Traditional | Innovita (Tangshan) Biological Technology Co.… | 11/22/2019SE |
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP…LCX · Traditional | Qingdao Hightop Biotech Co., Ltd. | 09/05/2019SE |
| K182328 | VeriClear Digital Early Result Pregnancy TestLCX · Traditional | True Diagnostics, Inc. | 05/15/2019SE |
| K190705 | WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip…LCX · Traditional | Wholepower Biotech Co., Ltd. | 04/15/2019SE |
| K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test…LCX · Traditional | Runbio Biotech Co.,Ltd | 02/22/2019SE |
| K183097 | Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step…LCX · Traditional | Weihai Kangzhou Biotechnology Engineering Co.… | 01/10/2019SE |
| K180771 | Acro HCG Pregnancy Rapid TestLCX · Traditional | Acro Biotech, Inc. | 05/18/2018SE |
| K172627 | David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteLCX · Traditional | Runbio Biotech Co.,Ltd | 03/28/2018SE |
| K173229 | Preview Digital Pregnancy TestLCX · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 03/12/2018SE |
| K172512 | ACRO HCG Pregnancy Rapid TestLCX · Special | Acro Biotech, Inc. | 02/02/2018SE |
| K171136 | LIA Pregnancy TestLCX · Traditional | Lia Diagnostics | 11/20/2017SE |
| K142754 | Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestLCX · Traditional | Sugentech, Inc. | 04/07/2016SE |
| K150063 | One Step hCG Pregnancy TestLCX · Traditional | Coretests, Inc. | 10/02/2015SE |
| K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test…LCX · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 08/07/2015SE |
| K132085 | One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test MidstreamLCX · Traditional | Co-Innovation Biotech Co., Ltd. | 11/12/2013SE |
| K131236 | Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream…LCX · Traditional | Ucp Biosciences, Inc. | 11/07/2013SE |
| K123567 | First Response Gold Digital Pregnancy TestLCX · Traditional | Church & Dwight Co., Inc. | 09/10/2013SE |
| K123436 | First Response Early Result Pregnancy TestLCX · Traditional | Church & Dwight Co., Inc. | 08/26/2013SE |
| K131931 | Chemtrue(R) HCG Pregnancy Urine Midstream TestLCX · Traditional | Chemtron Biotech, Inc. | 07/26/2013SE |
| K123703 | Healgen HCG One Step Pregnancy Test (Strip), Healgen HCG One Step Pregnancy Test…LCX · Traditional | Healgen Scientific,, LLC | 04/10/2013SE |
| K122907 | Fastep At-Home Pregnancy, HCG, Over the CounterLCX · Traditional | Polymed Therapeutics, Inc. | 03/14/2013SE |
| K123050 | Egens One Step HCG Urine Pregnancy Test Kit(S) (Strip, Cassette, Midstream I and…LCX · Traditional | Nantong Biotechnology Co., Ltd. | 02/05/2013SE |
| K112449 | Quikresponse One Step Midstream Early Pregrancy TestLCX · Traditional | Tianjin New Bay Bioresearch Co., Ltd. | 09/24/2012SE |
| K103487 | Fora PNC100 Digital Pregancy Test, TD-5301 Pregancy TestLCX · Traditional | Taidoc Technology Corporation | 10/04/2011SE |
| K102760 | Atlas Home Pregnancy Test (Midstream Format) Model 70172001LCX · Traditional | Atlas Medical | 08/03/2011SE |
| K103574 | Pregnancy One Step Rapid TestLCX · Traditional | Lehnus & Associates Consulting | 07/28/2011SE |
| K110889 | Ind One Step HCG Urine Pregnancy Test (Strip)LCX · Traditional | Ind Diagnostics, Inc. | 06/20/2011SE |
| K110433 | Clearblue Easy Pregnancy TestLCX · Special | SPD Development Company Limited | 05/12/2011SE |
| K081150 | Rapidan Optima Early Pregnancy Test and Toyo Pregnancy TestLCX · Traditional | Turklab Medical Devices, Inc. | 06/16/2009SE |
| K083716 | First Response Early Result Pregnancy Test (OTC)LCX · Traditional | Church & Dwight Co., Inc. | 06/08/2009SE |
| K071930 | One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy…LCX · Traditional | Blue Cross Bio-Medical Co., Ltd. | 12/18/2007SE |
| K062703 | One Step HCG Pregnancy TestLCX · Traditional | Ai DE Diagnostic Co., Ltd. | 07/23/2007SE |
| K062096 | Koreamedico Chextic HCG Urine Pregnancy TestLCX · Traditional | Koreamedico Co. , Ltd. | 05/07/2007SE |
| K070054 | First Response Gold Digital Pregnancy TestLCX · Traditional | Church & Dwight Co., Inc. | 05/04/2007SE |
| K053236 | David Pregnancy Test (Midstream)LCX · Traditional | Runbio Biotech Co.,Ltd | 07/18/2006SE |
| K061769 | E.P.T. Certainty 1-STEP Pregnancy TestLCX · Special | Unipath , Ltd. | 07/03/2006SE |
| K060825 | Multi-Use Electronic Pregnancy TestLCX · Traditional | Mizuho USA, Inc. | 06/19/2006SE |
| K060128 | Clearblue Easy Digital Pregnancy TestLCX · Traditional | Unipath , Ltd. | 05/25/2006SE |
| K053452 | Pure-Aid Pregnancy TestLCX · Traditional | Bio Focus Co., Lt. | 05/25/2006SE |
| K053138 | Myset Pregnancy TestLCX · Traditional | Ani Biotech OY | 03/01/2006SE |
| K060019 | Arton One-Step HCG Urinary Pregnancy Test (Strip), (Cassette), (Midstream)LCX · Traditional | Artron Laboratories, Inc. | 02/17/2006SE |
| K051963 | Be-Certain Pregnancy TestLCX · Traditional | Natureplex, LLC | 11/23/2005SE |
| K050305 | One Step HCG Pregnancy Urine Test Formats: Strip, Cassette and Midstream, Models BM-1-1…LCX · Traditional | Bioscreen Medical, Inc. | 05/23/2005SE |
| K050546 | Acon +/- Midstream Pregnancy TestLCX · Special | ACON Laboratories, Inc. | 05/20/2005SE |
| K050930 | E.P.T. Certainty Pregnancy TestLCX · Special | Unipath , Ltd. | 05/12/2005SE |
| K043231 | Proof Positive Electronic Pregnancy TestLCX · Traditional | Mizuho USA, Inc. | 04/25/2005SE |
| K043443 | One Step HCG Urine Pregnancy TestLCX · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 04/08/2005SE |
| K040866 | First Response One-Step Digital Pregnancy TestLCX · Traditional | Armkel, LLC | 10/19/2004SE |
| K042280 | Fact Plus One-Step Pregnancy Test KitLCX · Special | Unipath , Ltd. | 09/10/2004SE |
| K042151 | Acon Spectrum HCG Midstream Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 09/09/2004SE |
| K041748 | Azog, Inc. HCG One-Step Urine Home Pregnancy Test (Dip Stick, Cassette and Midstream)LCX · Abbreviated | Azog, Inc. | 08/09/2004SE |
| K041404 | Clearblue Easy Easy Read Pregnancy TestLCX · Special | Unipath , Ltd. | 06/08/2004SE |
| K041273 | One-Step Pregnancy TestLCX · Traditional | W.H.P.M., Inc. | 05/20/2004SE |
| K040341 | Clearblue Easy Earliest Results Pregnancy TestLCX · Special | Unipath , Ltd. | 03/08/2004SE |
| K040329 | Modification to E.P.T. Pregnancy TestLCX · Special | Unipath , Ltd. | 03/08/2004SE |
| K033658 | E.P.T. Pregnancy TestLCX · Special | Unipath , Ltd. | 01/16/2004SE |
| K033041 | Acon Quik-Check II Home Pregnancy Test StripLCX · Traditional | ACON Laboratories, Inc. | 11/21/2003SE |
| K032992 | Unimark Home Pregnancy Test DeviceLCX · Traditional | Biotech Atlantic, Inc. | 11/21/2003SE |
| K031798 | Good Morning TestLCX · Traditional | Standard Diagnostics, Inc. | 11/12/2003SE |
| K032939 | Ept Certainty Pregnancy TestLCX · Special | Unipath , Ltd. | 10/20/2003SE |
| K032661 | Acon Quick-Check II Home Pregnancy Test Device (Cassette)LCX · Traditional | ACON Laboratories, Inc. | 10/14/2003SE |
| K032510 | Acon Quik-Check II Midstream Home Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 09/22/2003SE |
| K032159 | Carestart-Pregnancy and Carestart Plus-PregnancyLCX · Traditional | Access Bio Incorporate | 09/05/2003SE |
| K031271 | One-Step Pregnancy TestLCX · Traditional | Amerisource Pharmacal, Inc. | 06/17/2003SE |
| K030659 | Clearblue Easy Digital Pregnancy TestLCX · Traditional | Unipath , Ltd. | 05/02/2003SE |
| K030533 | Accunate One-Step,Accunate One-Step Cassette, Accunate-Choice, Accunate Home Pregnancy…LCX · Traditional | Cenogenics Corp. | 04/17/2003SE |
| K023037 | Mid Stream Pregnancy TestLCX · Traditional | Advanced Diagnostics, Inc. | 04/09/2003SE |
| K030258 | First Response Pregnancy TestLCX · Traditional | Armkel, LLC | 02/25/2003SE |
| K023638 | Cassette/Urine HCGLCX · Traditional | Ind Diagnostic, Inc. | 01/03/2003SE |
| K023027 | Preg-Q Early Pregnancy TestLCX · Traditional | Yd Diagnostics | 12/16/2002SE |
| K023699 | Clearblue Easy Early Result Pregnancy TestLCX · Special | Unipath , Ltd. | 11/27/2002SE |
| K023126 | Ameditech Immutest HCG Pregancy TestLCX · Traditional | Ameditech, Inc. | 11/18/2002SE |
| K013907 | Inverness Medical Early Pregnancy TestLCX · Special | Cambridge Diagnostics Ireland, Ltd. | 12/18/2001SE |
| K013372 | Clearblue Easy Early Result Pregnancy TestLCX · Special | Unipath , Ltd. | 11/09/2001SE |
| K011551 | Sure Check Pregnancy TestLCX · Special | Chembio Diagnostic Systems, Inc. | 08/14/2001SE |
| K012215 | Quik-Check Home Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 08/07/2001SE |
| K002049 | Inverness Medical Early Pregnancy TestLCX · Special | Selfcare, Inc. | 07/27/2000SE |
| K993483 | Acon One Step Home Pregnancy Test StripLCX · Traditional | ACON Laboratories, Inc. | 01/20/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | Armkel, LLC | 12/21/1999SE |
| K993333 | Clearplan Easy II Home Pregnancy TestLCX · Traditional | Unipath , Ltd. | 12/16/1999SE |
| K993141 | At Home Quickcup Pregnancy Test, Model 9015LCX · Special | Phamatech | 11/08/1999SE |
| K991369 | Accudip Home Pregnancy And/Or Aimstick PregnancyLCX · Traditional | Germaine Laboratories, Inc. | 05/10/1999SE |
| K991193 | SAS Hcg-CheckLCX · Traditional | Sa Scientific, Inc. | 05/04/1999SE |
| K990262 | Clearplan Easy Home Pregnancy TestLCX · Traditional | Unipath , Ltd. | 04/07/1999SE |
| K990576 | Osom Card Pregnancy Test, Model 103LCX · Traditional | Wyntek Diagnostics, Inc. | 03/09/1999SE |
| K990373 | Fact Plus One Step Pregnancy TestLCX · Special | Abbott Laboratories | 02/22/1999SE |
| K984075 | Instant-View Pregnancy Urine Mid-Stream TestLCX · Traditional | Alfa Scientific Designs, Inc. | 02/16/1999SE |
| K983090 | Acon Midstream Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 11/18/1998SE |
| K981892 | Quick & Sure Onestep Home Pregnancy TestLCX · Traditional | Abacus Diagnostics | 08/18/1998SE |
| K981722 | Quidel Home Pregnancy TestLCX · Traditional | Quidel Corp. | 06/03/1998SE |
| K974059 | One Step Midstream HCG Pregnancy TestLCX · Traditional | International Newtech Development, Inc. | 04/09/1998SE |
| K980532 | Quickstream One Step Pregnancy Test Model Number 9012LCX · Traditional | Phamatech | 03/11/1998SE |
| K974821 | Bluetest(R) Pregnancy Test, Rapidvue(R) Pregnancy TestLCX · Traditional | Quidel Corp. | 01/26/1998SE |
| K974154 | Choice Accu-Test Pregnancy Test KitLCX · Traditional | Sa Scientific, Inc. | 12/19/1997SE |
| K974021 | Signal Pregnancy Test KitLCX · Traditional | Sa Scientific, Inc. | 12/19/1997SE |
| K973570 | Quick Card HCG One Step Pregnancy TestLCX · Traditional | Phamatech | 10/31/1997SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | Armkel, LLC | 10/27/1997SE |
| K973208 | First SignLCX · Traditional | Texas Immunology, Inc. | 10/20/1997SE |
| K972682 | Quickstick One Step HCG Pregnancy TestLCX · Traditional | Phamatech | 08/01/1997SE |
| K971286 | Ez Sure (Excel) Urine Midstream Pregnancy Home TestLCX · Traditional | Excel Scientific, Inc. | 05/08/1997SE |
| K970425 | Ez Sure Urine Dipstick Pregnancy Home TestLCX · Traditional | Excel Scientific, Inc. | 03/06/1997SE |
| K970008 | Advanced Quality Pregnancy TestLCX · Traditional | Bionike, Inc. | 02/18/1997SE |
| K965184 | Perfecta Pregnancy TestLCX · Traditional | Wyntek Diagnostics, Inc. | 02/04/1997SE |
| K970082 | Abbott Advisor One-Step Pregnancy TestLCX · Traditional | Abbott Laboratories | 01/24/1997SE |
| K963341 | Midstream Onestep Pregnancy Home TestLCX · Traditional | Syntron Bioresearch, Inc. | 12/02/1996SE |
| K964108 | Fact Plus Pregnancy TestLCX · Traditional | Direct Access Diagnostics | 11/18/1996SE |
| K964002 | Naturale HCG Pregnancy TesLCX · Traditional | Mizuho USA, Inc. | 11/07/1996SE |
| K962721 | Evidence Pregnancy TestLCX · Traditional | Saliva Diagnostic Systems | 10/01/1996SE |
| K962888 | Affirm One-Step Home Pregnancy TestLCX · Traditional | Athena Medical Corp. | 09/23/1996SE |
| K962580 | Ez Sure Onestep Early Pregnancy TestLCX · Traditional | Excel Scientific, Inc. | 08/29/1996SE |
| K962521 | Factplus One Step Pregnancy TestLCX · Traditional | Direct Access Diagnostics | 07/29/1996SE |
| K962219 | Quickstick One Step Pregnancy TEST(9010)LCX · Traditional | Phamatech | 07/23/1996SE |
| K962183 | Brand Name 1-STEP Pregnancy Test-May Be Marketed Under First Response, Answer, or Other…LCX · Traditional | Armkel, LLC | 07/10/1996SE |
| K961965 | Sure Check Pregnancy TestLCX · Traditional | Chembio Diagnostic Systems, Inc. | 06/24/1996SE |
| K961712 | TBD At-Home Pregnancy TestLCX · Traditional | Armkel, LLC | 05/31/1996SE |
| K960733 | Ministick Pregnancy TestLCX · Traditional | Vanguard Biomedical Corp. | 05/01/1996SE |
| K960316 | Clearblue EasyLCX · Traditional | Unipath , Ltd. | 04/29/1996SE |
| K960174 | Unimark Midstream Pregnancy Test StickLCX · Traditional | Biotech Atlantic, Inc. | 04/01/1996SE |
| K953606 | Best Pregnancy TestLCX · Traditional | Ameritek, Inc. | 03/22/1996SE |
| K960436 | Selfcare Early Pregnancy TestLCX · Traditional | Selfcare, Inc. | 03/19/1996SE |
| K960117 | Platform Onestep Pregnancy Home TestLCX · Traditional | Syntron Bioresearch, Inc. | 03/19/1996SE |
| K955903 | Selfcare Early Pregnancy TestLCX · Traditional | Cambridge Diagnostics Ireland, Ltd. | 03/06/1996SE |
| K954178 | Osom Pregnancy TestLCX · Traditional | Wyntek Diagnostics, Inc. | 10/23/1995SE |
| K954364 | Cameo Home Pregnancy TestLCX · Traditional | Quidel Corp. | 10/13/1995SE |
| K950354 | Human Chorionic Gonadotropin (HCG) Test System for the Early Detection of PregnancyLCX · Traditional | Ml Strategies, Inc. | 07/19/1995SE |
| K945514 | Lifesign(Tm) 1, Biosign(Tm) 1, Lifesign Plus(Tm), Lifesign(Tm) HCGLCX · Traditional | Princeton BioMeditech Corp. | 02/10/1995SE |
| K945846 | Advance(R) Pregnancy TestLCX · Traditional | Advanced Care Products | 01/27/1995SE |
| K945568 | HCG Midstream Pregnancy TestLCX · Traditional | Mizuho USA, Inc. | 01/17/1995SE |
| K941765 | HCG Pregnancy One Step Test Strip for OTC UseLCX · Traditional | Tcpi, Inc. | 10/20/1994SE |
| K941771 | Bodywise Pregnancey TestLCX · Traditional | Charlton Assoc. | 07/06/1994SE |
| K941355 | Pregnancy CheckLCX · Traditional | Sa Scientific, Inc. | 07/06/1994SE |
| K940637 | Predictor Home Pregnancy TestLCX · Traditional | Organon Teknika Corp. | 06/02/1994SE |
| K933794 | Ani Biocard(Tm) HCG TestLCX · Traditional | Canadian Bioclinical, Ltd. | 05/19/1994SE |
| K936013 | Evatest StripLCX · Traditional | Boehringer Mannheim Italia Spa | 02/25/1994SE |
| K934516 | Advance Pregnancy Test ModificationLCX · Traditional | Ortho Pharmaceutical Corp. | 02/24/1994SE |
| K934830 | HCG Pregnancy One Step Test StripLCX · Traditional | Tcpi, Inc. | 12/02/1993SE |
| K931997 | HCG Midstream Pregnancy TestLCX · Traditional | Mizuho USA, Inc. | 09/10/1993SE |
| K930488 | Besure Plus/(Midstream) One Step Preg Home TestLCX · Traditional | Syntron Bioresearch, Inc. | 04/06/1993SE |
| K930640 | Precise PregnancyLCX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/18/1993SE |
| K926308 | Lifesign HCG - One Step Home Pregnancy TestLCX · Traditional | Princeton Biomedix | 01/26/1993SE |
| K925189 | Pregnagen 1-STEP Pregnancy TestLCX · Traditional | Biogenex Laboratories | 01/06/1993SE |
| K925096 | Conceive One-Step Pregnancy TestLCX · Traditional | Quidel Corp. | 12/28/1992SE |
| K921099 | Syntron Quikstrip/E.Z. Strip Pregnancy Home TestLCX · Traditional | Syntron Bioresearch, Inc. | 05/29/1992SE |
| K921012 | Precise Chromatographic Immunoassay for HCGLCX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/08/1992SE |
| K914990 | Advance(R) Pregnancy TestLCX · Traditional | Ortho Pharmaceutical Corp. | 12/23/1991SE |
| K914304 | First Response(R) One-StepLCX · Traditional | Armkel, LLC | 10/17/1991SE |
| K914254 | Homeclinic One Step Pregnancy TestLCX · Traditional | Vanguard Biomedical Corp. | 10/17/1991SE |
| K912316 | Quikpac-Ii One Step Pregnancy Home TestLCX · Traditional | Syntron Bioresearch, Inc. | 07/24/1991SE |
| K911566 | Clearblue EasyLCX · Traditional | Unipath , Ltd. | 05/06/1991SE |
| K905742 | Clearblue EasyLCX · Traditional | Unipath , Ltd. | 02/13/1991SE |
| K904782 | Answer Quick and Simple At-Home Pregnancy TestLCX · Traditional | Carter Products | 12/06/1990SE |
| K901981 | Abbott Modified Fact Plus Pregnancy TestLCX · Traditional | Abbott Laboratories | 08/02/1990SE |
| K896482 | Perfect(Tm) One Step Early Pregnancy Test KitLCX · Traditional | Pacific Biotech, Inc. | 03/06/1990SE |
| K895560 | Modified Homeclinic Pregnancy TestLCX · Traditional | Vanguard Biomedical Corp. | 11/13/1989SE |
| K884489 | C&T Pregnancy Test KitLCX · Traditional | Healthcheck Corp. | 03/08/1989SE |
| K883430 | Pregna-Card(Tm) a Visual Home Pregnancy TestLCX · Traditional | Disease Detection International, Inc. | 01/30/1989SE |
| K883826 | Home Clinic Pregnancy TestLCX · Traditional | Vanguard Biomedical Corp. | 11/29/1988SE |
| K882232 | Discover(R)LCX · Traditional | Carter Products | 10/25/1988SE |
| K882588 | Blue Dot(Tm) Test for PregnancyLCX · Traditional | V-Tech, Inc. | 10/06/1988SE |
| K882416 | Clearblue EasyLCX · Traditional | Unipath , Ltd. | 07/28/1988SE |
| K880472 | Advance* and Daisy* Pregnancy TestLCX · Traditional | Advanced Care Products | 05/16/1988SE |
| K874823 | First Response 5 Minute Pregnancy TestLCX · Traditional | Tambrands, Inc. | 04/05/1988SE |
| K880069 | Leeco Pregnastick (Eia) Catalog #003LCX · Traditional | Leeco Diagnostics, Inc. | 02/11/1988SE |
| K874248 | Syntron Bioresearch U-Test Pregnancy TestLCX · Traditional | Syntron Bioresearch, Inc. | 11/04/1987SE |
| K871601 | Advance* Pregnancy Test Acp 2 Pregnancy TestLCX · Traditional | Advanced Care Products | 08/26/1987SE |
| K871996 | Abbott Biotell Pregnancy TestLCX · Traditional | Abbott Laboratories | 08/18/1987SE |
| K863341 | Cards(Tm) - Early Pregnancy TestLCX · Traditional | Pacific Biotech, Inc. | 01/14/1987SE |
| K864373 | Clearblue Pregnancy Testing Kit (Modification)LCX · Traditional | Unipath , Ltd. | 01/09/1987SE |
| K863999 | Vis-Cube Pregnancy Home Test,Cat. # JPL-042LCX · Traditional | Leeco Diagnostics, Inc. | 01/09/1987SE |
| K863841 | Tandem OTC HCG Pregnancy Test for Consumer UseLCX · Traditional | Hybritech, Inc. | 12/22/1986SE |
| K862207 | Quidel Beta Stick Pregnancy Test (Modification)LCX · Traditional | Quidel Corp. | 06/17/1986SE |
| K861946 | PTK Plus. Home Pregnancy TestLCX · Traditional | Healthcheck Corp. | 06/16/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1184-2026 Class II | PREGNANCY TEST 24CTPotential exposure of rodents and rodent activity in the distribution center. | Gold Star Distribution Inc | 12/26/2025Open, Classified |
| Z-0749-2026 Class II | Pregnancy TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0266-2024 Class II | FIRST RESPONSE 2 CT, SKU 902343Products were stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. | 10/04/2023Open, Classified |
| Z-0264-2024 Class II | VERIQUICK PREGNANCY TEST 1CT, SKU 901260Products were stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. | 10/04/2023Open, Classified |
| Z-0261-2024 Class II | CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260Products were stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. | 10/04/2023Open, Classified |
| Z-0066-2024 Class II | DiagnosUS Pregnancy Test Midstream REF 100-17Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0055-2024 Class II | PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTSUniversal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0054-2024 Class II | PrestiBio Pregnancy Strips REF 100-4 25 HCG Test StripsUniversal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0049-2024 Class II | Am I Pregnant? One Step HCG Pregnancy Test REF 100-17Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0042-2024 Class II | One Step Pregnancy Test REF 100-01Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-1350-2023 Class II | Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of…Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There… | Church & Dwight Inc | 01/25/2023Open, Classified |
| Z-1537-2022 Class II | FIRST RESPONSE 2 CT, SKU 902343Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-1528-2022 Class II | Veriquick Pregnancy Test 2CT, SKU 903756Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-1527-2022 Class II | VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-1526-2022 Class II | CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June… | Family Dollar Stores, Llc. | 06/23/2022Open, Classified |
| Z-2501-2010 | UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the…Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test… | Inverness Medical Professional Diagnostics | 02/12/2010Terminated |
| Z-2500-2010 | UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG…Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test… | Inverness Medical Professional Diagnostics | 02/12/2010Terminated |
| Z-1018-2010 | Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a…Lack of assurance of safety and efficacy: unapproved for marketing in the U.S., non-compliance with cGMP… | Mainline Technology, Inc. | 10/07/2009Terminated |
| Z-0469-2007 | Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136…False positives-the firm has received a higher than expected rate of complaints regarding false-positive… | Mizuho USA, Inc. | 11/17/2006Terminated |