Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpha Gamma Laboratory — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810011 | GAMMA STICK 125-1 TOBRAMYCIN RIA KIT | Alpha Gamma Laboratory | 1981-01-28 | 23 | 0 |
| K800538 | GAMMA STICK CORTISOL RIA KIT/STICK KIT | Alpha Gamma Laboratory | 1980-04-24 | 45 | 0 |
| K800537 | GAMMA STICK GENTAMICIN RIA KIT | Alpha Gamma Laboratory | 1980-04-24 | 45 | 0 |
| K780492 | GAMMA STIK 125I T3 UPTAKE KIT | Alpha Gamma Laboratory | 1978-04-28 | 32 | 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