Company ยท US
BioCheck Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2004. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
19recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 2 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 1 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 2004 | K041619 | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 Biocheck, Inc. | MMI |
| Jun 16, 2004 | K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 Biocheck, Inc. | DCN |
| Dec 19, 2002 | K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 Biocheck, Inc. | DRR |
| Jan 8, 2002 | K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT Biocheck, Inc. | MMI |
| Jul 20, 2001 | K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 Biocheck, Inc. | DCK |
| Oct 2, 2000 | K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 Biocheck, Inc. | CDZ |
| Sep 26, 2000 | K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 Biocheck, Inc. | JZG |
| Sep 24, 1999 | K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 Biocheck, Inc. | DBF |
| Sep 21, 1999 | K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 Biocheck, Inc. | DGC |
| Jul 22, 1999 | K991741 | BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 Biocheck, Inc. | JHI |
| Jun 22, 1999 | K991146 | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 Biocheck, Inc. | JLW |
| Jun 22, 1999 | K990993 | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 Biocheck, Inc. | JLW |
| Jun 2, 1999 | K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 Biocheck, Inc. | KLI |
| Jun 2, 1999 | K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 Biocheck, Inc. | CDP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2021 | BioCheck, Inc. 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. T Terminated |
KLI | K991432 |
| Mar 11, 2011 | BioCheck Inc Myeloperoxidase (MPO) ELISA kit ;
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
NTV | None listed |
| Mar 11, 2011 | BioCheck Inc CK-MB ELISA kit ;
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
JHY | None listed |
| Mar 11, 2011 | BioCheck Inc HSV-2 IgG ELISA kit ;
HSV-2 IgM ELISA kit;
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LGC | None listed |
| Mar 11, 2011 | BioCheck Inc HSV-1 IgG ELISA kit ;
HSV-1 IgM ELISA kit;
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LGC | None listed |
| Mar 11, 2011 | BioCheck Inc CVM IgG ELISA kit ;
CVM IgM ELISA kit
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
OMI | None listed |
| Mar 11, 2011 | BioCheck Inc Toxoplasma IgG ELISA kit ;
Toxoplasma IgM ELISA kit
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LGD | None listed |
| Mar 11, 2011 | BioCheck Inc Rubella IgG ELISA kit ;
Rubella IgM ELISA kit
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LFX | None listed |
| Mar 11, 2011 | BioCheck Inc 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. Terminated |
LYR | None listed |
| Mar 11, 2011 | BioCheck Inc Visual hCG ELISA kit
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
DHA | None listed |
| Mar 11, 2011 | BioCheck Inc Free beta-hCG ELISA kit
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
DHA | None listed |
| Mar 11, 2011 | BioCheck Inc Free PSA ELISA Kit.
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LTJ | None listed |
| Mar 11, 2011 | BioCheck Inc PSA ELISA Kit.
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LTJ | None listed |
| Mar 11, 2011 | BioCheck Inc CA19-9 ELISA Kit.
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
NIG | None listed |
| Mar 11, 2011 | BioCheck Inc CA15-3 ELISA Kit.
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LTK | None listed |
| Mar 11, 2011 | BioCheck Inc CA125 ELISA Kit.
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LTK | None listed |
| Mar 11, 2011 | BioCheck Inc CEA ELISA Kit.
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
DHX | None listed |
| Mar 11, 2011 | BioCheck Inc AFP ELISA Kit;
AFP ELISA kit (Extended range);
BioCheck, Foster City, CA 94404
Quantitative determination of AFP concentration in human serum. Terminated |
LOJ | None listed |
| Aug 20, 2010 | BioCheck Inc 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 Ci Terminated |
NUK | None listed |