Bioclinical Systems, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Bioclinical Systems, Inc.” (first 1985, latest 1995), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 | 2 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
| JXA | Kit, Screening, Urine | 1 | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
Most recent Bioclinical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | JTY | 1995-06-30 | 163 |
| K945911 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS | JTZ | 1995-04-04 | 123 |
| K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | JTY | 1994-02-09 | 229 |
| K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR | JTY | 1994-02-03 | 223 |
| K873086 | ROUND 1 | JXA | 1987-08-24 | 18 |
| K860334 | VISI-CHECK HLH TEST MONOCLONAL | CEP | 1986-04-21 | 82 |
| K860333 | MICRO-ELISA HLH TEST KIT MONOCLONAL | CEP | 1986-04-21 | 82 |
| K855227 | MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL | KLS | 1986-04-11 | 102 |
| K854059 | MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO | JHI | 1986-01-13 | 102 |
| K854379 | MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT | JLW | 1986-01-07 | 69 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bioclinical 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.
- Bioclinical Group (9 510(k)s)
- Bioclinical Laboratory Services, Inc. (6 510(k)s)
- Bioclinical Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bioclinical Systems, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Bioclinical Systems, Inc.” (first 1985, latest 1995), across 10 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 Bioclinical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioclinical Systems, Inc. is 82 days.
Which FDA product codes appear under Bioclinical Systems, Inc.?
The most frequent FDA product codes under this applicant name are JTY (Culture Media, For Isolation Of Pathogenic Neisseria, 3); CEP (Radioimmunoassay, Luteinizing Hormone, 2); CEJ (Tetraphenyl Borate, Colorimetry, Potassium, 1).
Next steps
- See all 13 Bioclinical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTY, Bioclinical 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.