Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Calbiochem — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K771993 | AFT SYSTEM | Calbiochem | 1977-11-02 | 12 | 0 |
| K760786 | ENZYMATIC LIPASE MAX-PACK REAGENT | Calbiochem | 1977-01-06 | 92 | 0 |
| K760366 | REAGENT, Y-GT MAX-PACK | Calbiochem | 1976-11-01 | 89 | 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