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

CDO — Predicate Candidate Screening

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

34 daysmedian FDA review time

66 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days
K033278	RANDOX URIC ACID	Randox Laboratories, Ltd.	2004-02-27	140
K992798	SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25,	Sigma Diagnostics, Inc.	1999-09-28	40
K982251	SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT	Sigma Diagnostics, Inc.	1998-08-18	53
K981766	URIC ACID	Abbott Laboratories	1998-06-19	31
K981189	URIC ACID	Abbott Laboratories	1998-05-07	35
K971485	URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY -	Trace America, Inc.	1997-05-27	34
K955752	OLYMPUS URIC ACID REAGENT	Olympus America, Inc.	1996-01-31	43
K932162	URIC ACID TEST ITEM NUMBER 65422	Em Diagnostic Systems, Inc.	1993-09-27	146
K923765	SYSTEMATE URICACID TEST, TECHNICON RA 1000	Em Diagnostic Systems, Inc.	1992-09-22	56
K903335	SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422	Em Diagnostic Systems, Inc.	1990-08-17	23
K875320	BIOTROL URIC ACID ENZYMATIQUE UV H.P.	Biotrol, USA, Inc.	1988-02-01	34
K873358	GEMENI URIC ACID U.V.	Electro-Nucleonics Laboratories, Inc.	1987-09-11	21
K863660	EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95	Em Diagnostic Systems, Inc.	1986-10-29	41
K844986	ROCHE REAGENTS REAGENT FOR URIC ACID	Roche Diagnostic Systems, Inc.	1985-01-18	23
K822884	URIC ACID 75CDO	Technicon Instruments Corp.	1982-10-27	29
K821872	ULTRACHEM URIC ACID AIDH	Harleco Diagnostics	1982-07-14	19
K821474	ULTRACHEM URIC ACID AIDH #65047	Emd Chemicals, Inc.	1982-06-03	16
K821465	ULTRACHEM URIC ACID AIDH, #65047	Emd Chemicals, Inc.	1982-06-02	15
K821167	URICASE (U.V.) URIC ACID	Syn-Kit, Inc.	1982-05-14	17
K813244	UV URIC ACID DETERMINATION	Biorent Diagnostic, Inc.	1981-12-08	20
K812500	ULTRACHEM URIC ACID ALDH, ITEM #65047	Harleco	1981-09-23	23
K802371	URIC ACID/ALDH	Boehringer Mannheim Corp.	1980-10-23	24
K801243	COBAS REAGENTS FOR URIC ACID	Roche Analytical Instruments, Inc.	1980-06-26	30
K800130	CENTRIFICHEM URIC ACID	Union Carbide Corp.	1980-02-13	26
K790834	UV URIC ACID DETERMINATION	The Dow Chemical Co.	1979-06-28	59
K781996	ACID REAGENT, URIC SINGLE VIAL	Calbiochem-Behring Corp.	1979-01-03	35
K780859	PRINCETON BIOMEDIX URICASE (UV)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1978-07-27	64
K771509	MULTISTAT III URIC ACID TEST	Instrumentation Laboratory CO	1977-09-13	39
K770831	STATZYME URIC ACID REAGENT	Worthington Biochemical Corp.	1977-07-11	66
K770767	IN VITRO DIAG. FOR URIC ACID	Smithkline Diagnostics, Inc.	1977-07-05	68
K760989	URIC ACID REAGENT SET	Worthington Biochemical Corp.	1976-12-09	34

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