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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Fermco Biochemics, Inc. — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

57 daysmedian FDA review time
84 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K843832TRIGLYCERIDES REAGENT SYSTEMFermco Biochemics, Inc.1984-11-27570
K823106RERMCO TEST CHLORIDE REAGENTFermco Biochemics, Inc.1982-11-16260
K822117FERMCOTEST CO2 REAGNETFermco Biochemics, Inc.1982-09-30730
K822118FERMCOTEST CREATININE TEST REAGENTFermco Biochemics, Inc.1982-09-30730
K810567GERMCO TEST R GLUCOSE TEST KITFermco Biochemics, Inc.1981-03-13100
K791066GLUCOSE GOD-PAP TRINDER METHOD TEST KITFermco Biochemics, Inc.1979-09-04840
K791018FERMCOTEST R BUN RATE REAGENT TEST KITFermco Biochemics, Inc.1979-07-17460
K781945GLUCOSE OXIDASE REAGENTFermco Biochemics, Inc.1979-01-17570

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