Data / Medical devices / United States / Biocheck, Inc.
Biocheck, Inc.: FDA-registered device maker in Pleasant Hill, CA, United States, 3 510(k) clearances
Biocheck, Inc. is registered with the FDA (registration 2953756) in Pleasant Hill, CA, United States. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 25, 1999. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2953756
- FEI number
- 3002564473
- Address
- 3451 Vincent Rd, Pleasant Hill, CA, United States, 94523
- Owner or operator
- BIOCHECK, INC. (9033543)
- Roles
- Complaint file establishment, Manufacturer for export, Repackager or relabeler
- First device listed
- December 13, 2022
- Registered through
- 2026
- Brand names listed
- ACTH (Adrenocorticotropic Hormone) ELISA, Androstenedione ELISA, Androstenedione (40 tests), Anti-Thyroid Peroxidase (Anti-TPO) ELISA, DxDATA Glial Fibrillary Acidic Protein (GFAP) CLIA Kit, DXDA-1003, DxDATA Protein Gene Product 9.5 (PGP 9.5) CLIA Kit, DXDA-1004, EIA-1911 Beta HCG ELISA, EIA-2111 Helicobacter pylori IgM ELISA, EIA-3476 EBV-VCA IgM ELISA and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | CDA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Ebv, Capsid | MCD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. | GMO | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Brain Trauma Assessment Test | QAT | 2 | Manufacturer for export | accessdata.fda.gov |
| Elisa, Trichinella Spiralis | MDT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Immunochemical, Thyroglobulin Autoantibody | JNL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Acth | CKG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Androstenedione | CIZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Pregnenolone | JNG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Reagents, Cysticercosis | MDJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Thyroglobulin, Antigen, Antiserum, Control | DDC | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 1999 | K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | DDC | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| August 19, 1998 | K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | CKG | Substantially Equivalent | Sangui Biotech, Inc. | accessdata.fda.gov |
| July 3, 1997 | K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | JNL | Substantially Equivalent | Monobind | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 14, 2021 | 88869 | Class II | Terminated | T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in t | Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. | accessdata.fda.gov |
| December 22, 2010 | 57506 | Not yet classified | Terminated | AFP ELISA Kit; AFP ELISA kit (Extended range); BioCheck, Foster City, CA 94404 Quantitative determination of AFP concentration in human serum. | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | accessdata.fda.gov |
| July 15, 2010 | 56291 | Not yet classified | Terminated | Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immun | Products were marketed without 510(k) for diagnostic use. Unapproved device. | accessdata.fda.gov |
Compare with other makers
- All makers of Radioimmunoassay, Acth
- All makers of Radioimmunoassay, Pregnenolone
- All makers of Radioimmunoassay, Androstenedione
- All makers of Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
- All makers of Immunochemical, Thyroglobulin Autoantibody
- All makers of Visual, Pregnancy Hcg, Prescription Use
Updated November 10, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.