Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Breit Laboratories, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
211 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851099 | IGM RHEUMATOID FACTOR TEST KIT | Breit Laboratories, Inc. | 1985-04-25 | 37 | 0 |
| K842137 | OCCULT BLOOD TEST | Breit Laboratories, Inc. | 1984-09-05 | 98 | 0 |
| K840527 | COLOTRAK OCCULT BLOOD TEST | Breit Laboratories, Inc. | 1984-09-05 | 211 | 0 |
| K832031 | ANTI-N DNA ANTIBODY TEST KIT | Breit Laboratories, Inc. | 1983-08-11 | 49 | 0 |
| K831927 | ANTINUCLEAR ANTIBODY TEST KIT | Breit Laboratories, Inc. | 1983-07-18 | 33 | 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