Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Specialties Laboratories · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
95 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852643 | UNI-PLATE | Medical Specialties Laboratories | 1985-08-08 | 48 | 0 |
| K844897 | HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 | Medical Specialties Laboratories | 1985-03-22 | 95 | 0 |
| K840114 | COAGULATION FACTOR DEFICIENT PLASMA | Medical Specialties Laboratories | 1984-02-04 | 24 | 0 |
| K823587 | UNI-CELL | Medical Specialties Laboratories | 1983-01-05 | 30 | 0 |
| K810268 | NORMLCERA | Medical Specialties Laboratories | 1981-03-06 | 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