Bioclinical Group: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Bioclinical Group” (first 1982, latest 1986), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 33 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 2 | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
Review panels
Most recent Bioclinical Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862968 | FREE T3 RADIOIMMUNOASSAY KIT | KHQ | 1986-09-25 | 50 |
| K853837 | LH/FSH RADIOIMMUNOASSAY KIT | CEP | 1985-10-16 | 30 |
| K832638 | CORTISOL RADIOIMMUNOASSAY KIT | CGR | 1983-09-12 | 39 |
| K823005 | BIO MAG FREE T4 RADIOIMMUNOASSAY KIT | CEC | 1982-12-15 | 64 |
| K823004 | BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT | CDX | 1982-11-05 | 24 |
| K822840 | RADIOIMMUNOASSAY, HUMAN CHORRIONIC | JHI | 1982-10-27 | 34 |
| K822515 | B-HCG RADIOIMMUNOASSAY KIT | JHI | 1982-09-14 | 25 |
| K821241 | FREE T4 RADIOIMMUNOASSAY KIT | CEC | 1982-06-01 | 33 |
| K821101 | TOTAL RADIOIMMUNOASSAY KIT | CDX | 1982-05-05 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Bioclinical Group.
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 Systems, Inc. (13 510(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 Group?
FDA lists 9 510(k) clearances under the applicant name “Bioclinical Group” (first 1982, latest 1986), across 6 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 Bioclinical Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioclinical Group is 33 days.
Which FDA product codes appear under Bioclinical Group?
The most frequent FDA product codes under this applicant name are CDX (Radioimmunoassay, Total Thyroxine, 2); CEC (Radioimmunoassay, Free Thyroxine, 2); JHI (Visual, Pregnancy Hcg, Prescription Use, 2).
Next steps
- See all 9 Bioclinical Group clearances with predicates and recalls
- Run predicate analysis for product code CDX, Bioclinical Group'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.