Biocheck HCG Enzyme Immunoassay Test Kit, Model BC-1027
FDA 510(k) K991741 · Biocheck, Inc.
510(k) numberK991741
Submission
- Device name
- Biocheck HCG Enzyme Immunoassay Test Kit, Model BC-1027
- Applicant
- Biocheck, Inc.
Northridge, CA, US - Received
- May 21, 1999
- Decision date
- July 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K041619 | Bio Check Whole Blood/Plasma/Sermon Model #801116MMI · Traditional | 12/17/2004SE |
| K040030 | Biocheck CARDIAC-1 CRP Rapid Test, Model BC-804114DCN · Traditional | 06/16/2004SE |
| K022660 | Biocheck Myoglobin Elisa, Model BC-1117DRR · Traditional | 12/19/2002SE |
| K013062 | Biocheck Human Cardiac Troponin-I Immunoassay Test KitMMI · Traditional | 01/08/2002SE |
| K003851 | Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model BC-1119DCK · Traditional | 07/20/2001SE |
| K002294 | Biocheck Testosterone Eia, Model BC-1115CDZ · Traditional | 10/02/2000SE |
| K001022 | Biocheck, Inc. B-2 Microglobin Enzyme Immunoasay Test Kit, Model BC-1061JZG · Traditional | 09/26/2000SE |
| K992517 | Biocheck Ferritin Elisa Model BC-1025DBF · Traditional | 09/24/1999SE |
| K992528 | Biocheck Ige Elisa, Model BC-1035DGC · Traditional | 09/21/1999SE |
| K991146 | TSH Enzyme Immunoassay Test Kit, Model #BC-1001JLW · Traditional | 06/22/1999SE |
Questions and answers
When was Biocheck HCG Enzyme Immunoassay Test Kit, Model BC-1027 cleared by the FDA?
Biocheck HCG Enzyme Immunoassay Test Kit, Model BC-1027 (K991741) received a 510(k) decision of Substantially Equivalent on July 22, 1999, 62 days after the submission was received.
What is the product code of K991741?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.