Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medilab Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
70 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841863 | MONO-TEC | Medilab Corp. | 1984-06-13 | 40 | 0 |
| K841862 | IMMU-TEC | Medilab Corp. | 1984-06-13 | 40 | 0 |
| K840291 | MCS ALBUMIN REAGENT | Medilab Corp. | 1984-03-30 | 66 | 0 |
| K840290 | MCS TOTAL PROTEIN REAGENT | Medilab Corp. | 1984-03-30 | 66 | 0 |
| K840289 | LYSE-TEC | Medilab Corp. | 1984-03-05 | 41 | 0 |
| K832918 | PREGNA-TEC | Medilab Corp. | 1983-11-03 | 70 | 0 |
| K832527 | PREGNA-TEC | Medilab Corp. | 1983-09-12 | 45 | 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