Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Murex Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
75 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862048 | SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM | Murex Corp. | 1986-06-19 | 21 | 0 |
| K861458 | MUREX SUDS TOXO | Murex Corp. | 1986-06-13 | 56 | 0 |
| K861282 | MUREX SUDS RUBELLA | Murex Corp. | 1986-06-13 | 67 | 0 |
| K860451 | MUREX (TM), SUDS (TM), HCG ASSAY | Murex Corp. | 1986-04-21 | 75 | 0 |
| K860576 | MUREX SUDS GROUP A STREP | Murex Corp. | 1986-04-04 | 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