Atlas FDA

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

Sterling Biochemical, Inc. — Predicate Candidate Screening

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

46 daysmedian FDA review time
78 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K844998GLUCOSE(HEXOKINASE) REAGENT SETSterling Biochemical, Inc.1985-01-18230
K844251ALT/GPT REAGENT SETSterling Biochemical, Inc.1985-01-08670
K843332ALKALINE PHOSPHATASE REAGENT SETSterling Biochemical, Inc.1984-09-14180
K842521AST/GOT REAGENT SET UV RATESterling Biochemical, Inc.1984-08-12460
K840064UREA NITROGEN REAGENT SETSterling Biochemical, Inc.1984-06-141570
K834084HYDROXYBUTYRATE DEHYDROGENASE REAGENTSterling Biochemical, Inc.1984-02-04680
K834045URIC ACID REAGENT SETSterling Biochemical, Inc.1984-01-30680
K833864AMYLASE REAGENT SET-MODIFIED CARAWAYSterling Biochemical, Inc.1984-01-13670
K833062SERUM CHOLINESTERASE REAGENT SETSterling Biochemical, Inc.1983-11-25780
K831874LIPASE REAGENT SETSterling Biochemical, Inc.1983-08-12600
K831415LACTIC DEHYDROGENASE REAGENT SETSterling Biochemical, Inc.1983-06-16450
K830672CREATINE KINASE REAGENT SETSterling Biochemical, Inc.1983-04-05320
K823341TRIGLYCERIDES REAGENT SET TAG-GKSterling Biochemical, Inc.1982-12-22440
K822237UREA NITROGEN REAGENT SET (MOD. BERTHELSterling Biochemical, Inc.1982-08-16190
K820950TOTAL CHOLESTEROL REAGENT SETSterling Biochemical, Inc.1982-04-26200

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