Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laboratory Technologies, Inc. — 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) |
|---|---|---|---|---|---|
| K921536 | ACCULYTE CHEMILUMINESCENCE ANALYZER | Laboratory Technologies, Inc. | 1993-10-12 | 580 | 0 |
| K900087 | GENESYS 6000 GAMMA COUNTER | Laboratory Technologies, Inc. | 1990-07-19 | 195 | 0 |
| K882194 | GEMINII GAMMA COUNTER | Laboratory Technologies, Inc. | 1988-08-04 | 71 | 0 |
| K851689 | GENESYS GAMMA COUNTER | Laboratory Technologies, Inc. | 1985-08-07 | 103 | 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