Bio-Chem Laboratory Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Bio-Chem Laboratory Systems, Inc.” (first 1992, latest 1995), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 184 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KHO | Fluorometer, For Clinical Use | 1 | 1 |
Review panels
Most recent Bio-Chem Laboratory Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945271 | ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM | JJE | 1995-04-20 | 184 |
| K930689 | AUTOBEAD THYROID UPTAKE | KHO | 1993-11-10 | 273 |
| K930006 | AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT | JLW | 1993-09-09 | 248 |
| K926563 | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT | CDX | 1993-03-18 | 77 |
| K924084 | ATAC 6000 CHEMISTRY ANALYZER | JJE | 1992-09-29 | 47 |
Recalls
openFDA lists no recalls under a recalling firm named Bio-Chem Laboratory Systems, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bio-Chem Laboratories (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio-Chem Laboratory Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Bio-Chem Laboratory Systems, Inc.” (first 1992, latest 1995), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bio-Chem Laboratory Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Chem Laboratory Systems, Inc. is 184 days.
Which FDA product codes appear under Bio-Chem Laboratory Systems, Inc.?
The most frequent FDA product codes under this applicant name are JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 2); CDX (Radioimmunoassay, Total Thyroxine, 1); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 1).
Next steps
- See all 5 Bio-Chem Laboratory Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJE, Bio-Chem Laboratory Systems, 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.