Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mcb Manufacturing Chemists, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
35 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801212 | WRIGHTS RAPID STAIN | Mcb Manufacturing Chemists, Inc. | 1980-05-30 | 10 | 0 |
| K800847 | ENTELLAN | Mcb Manufacturing Chemists, Inc. | 1980-05-08 | 23 | 0 |
| K792026 | WRIGHTS RAPID STAIN | Mcb Manufacturing Chemists, Inc. | 1979-11-13 | 35 | 0 |
| K791929 | WRIGHTS RAPID STAIN | Mcb Manufacturing Chemists, Inc. | 1979-10-11 | 14 | 0 |
| K782066 | EXETRELUT | Mcb Manufacturing Chemists, Inc. | 1979-01-03 | 21 | 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