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

Worthington Biochemical Corp. — Predicate Candidate Screening

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

28 daysmedian FDA review time
66 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K780389HDL REAGENT SET FOR LIPOPROTEINSWorthington Biochemical Corp.1978-04-19400
K780096LDH ISOENZYME CONTROL SERUMWorthington Biochemical Corp.1978-03-03440
K772356LDH ISOENZYME COLUMN REAGENT SETWorthington Biochemical Corp.1978-01-24280
K772025URIC ACID STD. FOR QUANT. URIC ACIDWorthington Biochemical Corp.1977-11-11150
K771143INORGANIC PHOSPHORUS STANDARDSWorthington Biochemical Corp.1977-07-11140
K770831STATZYME URIC ACID REAGENTWorthington Biochemical Corp.1977-07-11660
K771001STATZYME GLUCOSEWorthington Biochemical Corp.1977-07-11380
K770470WORTHINGTON BUNWorthington Biochemical Corp.1977-06-02840
K770277CHOLESTEROL STANDARDSWorthington Biochemical Corp.1977-03-01150
K761262TRIGLYCERIDES (LIPASE) REAGENT SETWorthington Biochemical Corp.1976-12-29130
K761263CHOLESTEROL AUTOMATED REAGENTWorthington Biochemical Corp.1976-12-29130
K760989URIC ACID REAGENT SETWorthington Biochemical Corp.1976-12-09340
K760990INORGANIC PHOSPHOROUS REAGENTWorthington Biochemical Corp.1976-11-16110

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