Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 Test
FDA 510(k) K981165 · Germaine Laboratories, Inc.
510(k) numberK981165
Submission
- Device name
- Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 Test
- Applicant
- Germaine Laboratories, Inc.
San Antonio, TX, US - Received
- March 31, 1998
- Decision date
- April 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHI – Visual, Pregnancy Hcg, Prescription Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo TestJHI · Traditional | Innovita (Tangshan) Biological Technology Co.… | 08/02/2024SE |
| K203272 | Alltest Pregnancy Rapid Combo Test CassetteJHI · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 01/31/2022SE |
| K172322 | Atellica IM Total hCG (ThCG)JHI · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/29/2018SE |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result…JHI · Traditional | True Diagnostics, Inc. | 12/22/2017SE |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…JHI · Traditional | Assure Tech. Co., Ltd. | 02/24/2016SE |
| K130456 | Wunder Pregnancy TestJHI · Traditional | James Nguyen | 04/08/2014SE |
| K132834 | Fastep S10 HCG Serum/Urine Combo TestJHI · Traditional | Polymed Therapeutics, Inc. | 01/09/2014SE |
| K131166 | Sofia(R) HCG FiaJHI · Traditional | Quidel Corp. | 08/02/2013SE |
| K123844 | Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…JHI · Traditional | Chemtron Biotech, Inc. | 05/30/2013SE |
| K112101 | Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsJHI · Traditional | Polymed Therapeutics, Inc. | 07/17/2012SE |
More from Polymed Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051727 | Aimstick Urine Reagent StripsCEN · Traditional | 10/26/2005SE |
| K013857 | Aimstep PregnancyDHA · Traditional | 01/22/2002SE |
| K991369 | Accudip Home Pregnancy And/Or Aimstick PregnancyLCX · Traditional | 05/10/1999SE |
| K980531 | Aimstep PregnancyJHI · Traditional | 03/06/1998SE |
| K974512 | Aimstick PBD Combo PregnancyDHA · Traditional | 01/02/1998SE |
| K974368 | Aimstick PBD PregnancyDHA · Traditional | 01/02/1998SE |
| K973825 | Midstream Home Regnancy TestDHA · Traditional | 12/19/1997SE |
Questions and answers
When was Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 Test cleared by the FDA?
Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 Test (K981165) received a 510(k) decision of Substantially Equivalent on April 16, 1998, 16 days after the submission was received.
What is the product code of K981165?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.