Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Pro-Lab Diagnostics — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944421 | E.COLI 0157 LATEX TEST | Pro-Lab Diagnostics | 1994-12-15 | 119 | 0 |
| K924331 | TRANSYSTEM LIQUID STUART MEDIUM | Pro-Lab Diagnostics | 1992-12-24 | 119 | 0 |
| K924330 | TRANSYSTEM AMIES WITH CHARCOAL | Pro-Lab Diagnostics | 1992-12-24 | 119 | 0 |
| K924328 | TRANSYSTEM LIQUID AMIES MEDIUM | Pro-Lab Diagnostics | 1992-12-24 | 119 | 0 |
| K924329 | TRANSYSTEM AMIES W/O CHARCOAL | Pro-Lab Diagnostics | 1992-12-24 | 119 | 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