Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Enzyme Technology, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
267 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912027 | CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1992-01-30 | 267 | 0 |
| K912028 | URIC ACID (URICASE) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1991-12-18 | 224 | 0 |
| K905227 | GLUCOSE (HK) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1991-03-11 | 111 | 0 |
| K905226 | TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1990-12-11 | 21 | 0 |
| K896073 | CHOLESTEROL, UNIVERSAL ET | Enzyme Technology, Inc. | 1989-12-12 | 54 | 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