BioCheck Inc
Medical device manufacturer in South San Francisco, CA.
14510(k) clearances
0PMA approvals
19recalls
Device types
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 2
- MMI Immunoassay Method, Troponin Subunit 2
- CDP Radioimmunoassay, Total Triiodothyronine 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- JHI Visual, Pregnancy Hcg, Prescription Use 1
- DGC Ige, Antigen, Antiserum, Control 1
- DBF Ferritin, Antigen, Antiserum, Control 1
- JZG System, Test, Beta-2-Microglobulin… 1
- CDZ Radioimmunoassay, Testosterones And… 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- DRR Amplifier And Signal Conditioner… 1
- DCN System, Test, C-Reactive Protein 1
510(k) clearances
| 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 |
| K991741 | Biocheck HCG Enzyme Immunoassay Test Kit, Model BC-1027JHI · Traditional | 07/22/1999SE |
| K991146 | TSH Enzyme Immunoassay Test Kit, Model #BC-1001JLW · Traditional | 06/22/1999SE |
| K990993 | Biocheck Sensitive TSH (S-Tsh) Enzyme Immunoassay Test Kit; Catalog Number: BC-1003JLW · Traditional | 06/22/1999SE |
| K991432 | Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007KLI · Traditional | 06/02/1999SE |
| K991311 | Total T3 Enzyme Immunoassay Test Kit, Model BC-1005CDP · Traditional | 06/02/1999SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0214-2022 Class II | T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This…Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. | 10/14/2021Terminated |
| Z-1642-2011 | Myeloperoxidase (MPO) ELISA kit ; BioCheck, Foster City, CA 9440. Quantitative…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1641-2011 | CK-MB ELISA kit ; BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1640-2011 | HSV-2 IgG ELISA kit ; HSV-2 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1639-2011 | HSV-1 IgG ELISA kit ; HSV-1 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1638-2011 | CVM IgG ELISA kit ; CVM IgM ELISA kit BioCheck, Foster City, CA 9440. Quantitative…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1637-2011 | Toxoplasma IgG ELISA kit ; Toxoplasma IgM ELISA kit BioCheck, Foster City, CA 9440.…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1636-2011 | Rubella IgG ELISA kit ; Rubella IgM ELISA kit BioCheck, Foster City, CA 9440.…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1635-2011 | H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1634-2011 | Visual hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1633-2011 | Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1632-2011 | Free PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1631-2011 | PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1630-2011 | CA19-9 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1629-2011 | CA15-3 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1628-2011 | CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1627-2011 | CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-1626-2011 | AFP ELISA Kit; AFP ELISA kit (Extended range); BioCheck, Foster City, CA 94404…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | 12/22/2010Terminated |
| Z-2243-2010 | Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an…Products were marketed without 510(k) for diagnostic use. Unapproved device. | 07/15/2010Terminated |