Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Enzo Biochem, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
173 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880604 | COLORGENE HSV DNA HYBRIDIZATION TEST | Enzo Biochem, Inc. | 1988-08-03 | 173 | 0 |
| K881907 | HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD | Enzo Biochem, Inc. | 1988-07-08 | 63 | 0 |
| K875367 | COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV | Enzo Biochem, Inc. | 1988-03-28 | 88 | 0 |
| K872576 | COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION | Enzo Biochem, Inc. | 1987-12-04 | 157 | 0 |
| K870733 | COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. | Enzo Biochem, Inc. | 1987-05-26 | 90 | 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