Biocheck, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Biocheck, Inc.” (first 1999, latest 2004), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (8)
- Immunology (5)
- Cardiovascular (1)
Most recent Biocheck, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041619 | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 | MMI | 2004-12-17 | 185 |
| K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | DCN | 2004-06-16 | 161 |
| K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | DRR | 2002-12-19 | 132 |
| K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT | MMI | 2002-01-08 | 118 |
| K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 | DCK | 2001-07-20 | 220 |
| K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 | CDZ | 2000-10-02 | 67 |
| K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | JZG | 2000-09-26 | 180 |
| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | DBF | 1999-09-24 | 58 |
| K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | DGC | 1999-09-21 | 55 |
| K991741 | BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 | JHI | 1999-07-22 | 62 |
4 earlier clearances. See the full list in Caduvo.
Recalls
19 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2021-10-14.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biocheck, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Biocheck, Inc.” (first 1999, latest 2004), across 12 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biocheck, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biocheck, Inc. is 84 days.
Which FDA product codes appear under Biocheck, Inc.?
The most frequent FDA product codes under this applicant name are JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 2); MMI (Immunoassay Method, Troponin Subunit, 2); CDP (Radioimmunoassay, Total Triiodothyronine, 1).
Next steps
- See all 14 Biocheck, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JLW, Biocheck, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.