Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

CDH — Predicate Candidate Screening

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

50 daysmedian FDA review time

77 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K850933	URIC ACID	Dilab, Inc.	1985-06-25	110
K841067	URIC ACID REAGENT SET	Medical Specialties, Inc.	1984-05-01	50
K821213	URIC ACID REAGENT SET	Omega Medical Electronics	1982-07-13	77
K813076	PHOSPHOTUNGSTATE REDUCTION, URIC ACID	American Monitor Corp.	1981-11-16	14
K810088	URIC ACID (TPTZ) COLORINMETRIC	Bio-Analytics Laboratories, Inc.	1981-01-28	15
K800672	SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC	Diagnostic Solutions, Inc.	1980-05-28	63
K800190	STANBIO DIRECT URIC ACID TEST SET #0770	Stanbio Laboratory	1980-02-13	15
K792412	ELVI URIC ACID	Volu Sol Medical Industries	1979-12-07	11
K792403	ELVI URIC ACID-COLORIMETRIC METHOD	Volu Sol Medical Industries	1979-12-07	11
K790019	SERUM, URIC ACID DETERMINATION	Fisher Scientific Co., LLC	1979-02-26	54
K772082	ENZAC URIC ACID 100-TEST KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1977-11-28	25
K771842	URIC ACID	Gamma Enterprises, Inc.	1977-10-25	34
K770564	URIC ACID TEST KIT	Mallinckrodt Critical Care	1977-06-03	71
K770459	URIC ACID PROCEDURE, TEKPOINT DIRECT	Icn Pharmaceuticals, Inc.	1977-04-29	52
K760477	REAGENTS-4 FOR URIC ACID DETERMINATION	Simmler & Son, Inc.	1976-10-29	73

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