Atlas FDA

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

Genchem, Inc. — Predicate Candidate Screening

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

257 daysmedian FDA review time
257 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090283CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAGenchem, Inc.2009-06-051200
K040974GLUCOSE OXIDASE, GLUCOSEGenchem, Inc.2004-12-272570
K040977GENCHEM ELECTROLYTE BUFFERGenchem, Inc.2004-12-272570
K040972CALCIUM, AZO DYE REAGENTGenchem, Inc.2004-12-272570
K040976GENCHEM CREATININE REAGENTGenchem, Inc.2004-12-272570
K040975GENCHEM CO2 ACID REAGENTGenchem, Inc.2004-12-272570
K040973BUN REAGENTGenchem, Inc.2004-12-272570
K040971GENCHEM ISE ELECTROLYTE REFERENCEGenchem, Inc.2004-12-222520

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