Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioclinical Group — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
64 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862968 | FREE T3 RADIOIMMUNOASSAY KIT | Bioclinical Group | 1986-09-25 | 50 | 0 |
| K853837 | LH/FSH RADIOIMMUNOASSAY KIT | Bioclinical Group | 1985-10-16 | 30 | 0 |
| K832638 | CORTISOL RADIOIMMUNOASSAY KIT | Bioclinical Group | 1983-09-12 | 39 | 0 |
| K823005 | BIO MAG FREE T4 RADIOIMMUNOASSAY KIT | Bioclinical Group | 1982-12-15 | 64 | 0 |
| K823004 | BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT | Bioclinical Group | 1982-11-05 | 24 | 0 |
| K822840 | RADIOIMMUNOASSAY, HUMAN CHORRIONIC | Bioclinical Group | 1982-10-27 | 34 | 0 |
| K822515 | B-HCG RADIOIMMUNOASSAY KIT | Bioclinical Group | 1982-09-14 | 25 | 0 |
| K821241 | FREE T4 RADIOIMMUNOASSAY KIT | Bioclinical Group | 1982-06-01 | 33 | 0 |
| K821101 | TOTAL RADIOIMMUNOASSAY KIT | Bioclinical Group | 1982-05-05 | 15 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda