Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Roseville Medical Laboratoriesu · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
28 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850731 | CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K850732 | CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K850733 | MULTIPURPOSE CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K850734 | DIFFERENTIAL CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K850736 | SELECTIVE CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K850737 | TRANSPORT CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K850738 | SUPPLEMENT FOR CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-20 | 28 | 0 |
| K850735 | ENRICHED CULTURE MEDIUM | Roseville Medical Laboratoriesu | 1985-03-16 | 24 | 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