BioCheck Inc
Pleasant Hill, CA, US
BIOCHECK, INC. appears in FDA device records in Pleasant Hill, CA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 19 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for BioCheck Inc between 1999 and 2004. The busiest year on record is 1999, with 7. The most recent is 2004, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 7 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 2 |
| 2004 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041619 | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 | MMI | Substantially Equivalent | |
| K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | DCN | Substantially Equivalent | |
| K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | DRR | Substantially Equivalent | |
| K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT | MMI | Substantially Equivalent | |
| K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 | DCK | Substantially Equivalent | |
| K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 | CDZ | Substantially Equivalent | |
| K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | JZG | Substantially Equivalent | |
| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | DBF | Substantially Equivalent | |
| K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | DGC | Substantially Equivalent | |
| K991741 | BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 | JHI | Substantially Equivalent | |
| K991146 | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 | JLW | Substantially Equivalent | |
| K990993 | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 | JLW | Substantially Equivalent | |
| K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | KLI | Substantially Equivalent | |
| K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | CDP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2953756 | 3002564473 | BIOCHECK, INC. | 3451 Vincent Rd, Pleasant Hill, CA 94523 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
- DRRAmplifier And Signal Conditioner, Biopotential
- GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni
- GMOAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
- QATBrain Trauma Assessment Test
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- MDTElisa, Trichinella Spiralis
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DBFFerritin, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- MMIImmunoassay Method, Troponin Subunit
- JNLImmunochemical, Thyroglobulin Autoantibody
- CKGRadioimmunoassay, Acth
- CIZRadioimmunoassay, Androstenedione
- JNGRadioimmunoassay, Pregnenolone
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- MDJReagents, Cysticercosis
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DCNSystem, Test, C-Reactive Protein
- DDCThyroglobulin, Antigen, Antiserum, Control
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0214-2022 | 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 the diagnosis and treatment of thyroid disorders. | Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. | Class II | Terminated | |
| Z-1642-2011 | Myeloperoxidase (MPO) ELISA kit ; BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1641-2011 | CK-MB ELISA kit ; BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1640-2011 | HSV-2 IgG ELISA kit ; HSV-2 IgM ELISA kit; BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1639-2011 | HSV-1 IgG ELISA kit ; HSV-1 IgM ELISA kit; BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1638-2011 | CVM IgG ELISA kit ; CVM IgM ELISA kit BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1637-2011 | Toxoplasma IgG ELISA kit ; Toxoplasma IgM ELISA kit BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1636-2011 | Rubella IgG ELISA kit ; Rubella IgM ELISA kit BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1635-2011 | H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG ELISA kit BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1634-2011 | Visual hCG ELISA kit BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1633-2011 | Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1632-2011 | Free PSA ELISA Kit. BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1631-2011 | PSA ELISA Kit. BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1630-2011 | CA19-9 ELISA Kit. BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1629-2011 | CA15-3 ELISA Kit. BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1628-2011 | CA125 ELISA Kit. BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1627-2011 | CEA ELISA Kit. BioCheck, Foster City, CA 9440. 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). | Terminated | ||
| Z-1626-2011 | 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). | Terminated | ||
| Z-2243-2010 | 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 Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma. | Products were marketed without 510(k) for diagnostic use. Unapproved device. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets BioCheck Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain