Product Code: KNK FDA class 1 21 CFR 862.1775

Acid, Uric, Uricase (Colorimetric)

Clinical Chemistry

The Uric Acid Uricase Colorimetric test is an in vitro diagnostic assay used in clinical chemistry laboratories to measure uric acid concentrations in blood or urine using the uricase enzymatic colorimetric method, supporting the diagnosis and monitoring of gout, hyperuricemia, and related metabolic conditions. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KNK and the applicable regulation is 21 CFR 862.1775 in the Clinical Chemistry specialty.

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510(k)s

118

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: KNK
Device Class: FDA class 1
Regulation Number: 862.1775
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 118 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K102568	URIC ACID MODEL 3P39	May 06, 2011	Substantially Equivalent	ABBOTT LABORATORIES
K062862	OLYMPUS URIC ACID REAGENT, MODEL OSR6X98	Apr 06, 2007	Substantially Equivalent	OLYMPUS AMERICA, INC.
K040467	VITALAB URIC ACID REAGENT	Mar 08, 2004	Substantially Equivalent	CLINICAL DATA, INC.
K031044	ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR	Jul 15, 2003	Substantially Equivalent	CLINICAL DATA, INC.
K022096	URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Mar 18, 2003	Substantially Equivalent	BAYER DIAGNOSTICS CORP.
K023550	WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA	Dec 09, 2002	Substantially Equivalent	WIENER LABORATORIES S.A.I.C.
K012038	JAS URIC ACID LIQUID REAGENT	Aug 21, 2001	Substantially Equivalent	JAS Diagnostics, Inc.
K010421	WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105	Apr 13, 2001	Substantially Equivalent	WIENER LABORATORIES S.A.I.C.
K993469	WAKO L-TYPE UA F TEST	Nov 09, 1999	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K991247	URIC ACID, MODEL UA112-01	May 25, 1999	Substantially Equivalent	A.P. TOTAL CARE, INC.
K981604	CARESIDE URIC ACID	Jun 25, 1998	Substantially Equivalent	CARESIDE, INC.
K970919	SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT	May 21, 1997	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K970867	URIC ACID REAGENT	Apr 21, 1997	Substantially Equivalent	DERMA MEDIA LAB., INC.
K971133	URIC, UA, OR URIC ACID	Apr 14, 1997	Substantially Equivalent	CAROLINA LIQUID CHEMISTRIES CORP.
K970560	URIC ACID (LIQUID) REAGENT SET	Mar 11, 1997	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K961586	URIC ACID-SL ASSAY CATALOGUE NO. 237-60	Jul 23, 1996	Substantially Equivalent	DIAGNOSTIC CHEMICALS LTD.
K955496	URIC ACID CATALOGE# 220-93/94/97	Feb 23, 1996	Substantially Equivalent	DIAGNOSTIC CHEMICALS LTD.
K943002	URIC ACID QVET	Dec 02, 1994	Substantially Equivalent	PRISMA SYSTEMS
K932728	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)	Apr 25, 1994	Substantially Equivalent	EASTMAN KODAK COMPANY
K931350	IL TEST URIC ACID	Oct 01, 1993	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K923503	URIC ACID ENZYMATIC COLORIMERIC KIT	Jul 22, 1993	Substantially Equivalent	RANDOX LABORATORIES, LTD.
K925113	OLYMPUS URIC ACID REAGENT	Jan 26, 1993	Substantially Equivalent	OLYMPUS CORP.
K924129	MILES AUTO METH DETERMIN OF URIC ACID IN URINE	Sep 22, 1992	Substantially Equivalent	HERAEUS KULZER, INC.
K923414	SYNERMED 600 NM URIC ACID REAGENT KIT	Sep 22, 1992	Substantially Equivalent	SYNERMED, INC.
K922756	OLYMPUS URIC ACID REAGENT	Jul 17, 1992	Substantially Equivalent	OLYMPUS CORP.
K922762	ROCHE REAGENT FOR URIC ACID--MODIFICATION	Jul 09, 1992	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K914158	URIC ACID REAGENT SET	Feb 21, 1992	Substantially Equivalent	TECH INTL. CO.
K912028	URIC ACID (URICASE) REAGENT, UNIVERSAL	Dec 18, 1991	Substantially Equivalent	ENZYME TECHNOLOGY, INC.
K913706	ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34	Sep 27, 1991	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K903727	SYNERMED URIC ACID REAGENT KIT	Sep 27, 1990	Substantially Equivalent	SYNERMED, INC.
K896225	COBAS READY PROFILE 2 REAGENT STRIP	Jun 26, 1990	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K901001	URIC ACID TEST KIT	May 23, 1990	Substantially Equivalent	ELITE TECHNOLOGY, INC.
K901544	WAKO(TM) AUTOKIT URIC ACID	May 14, 1990	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K901693	TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC	Apr 25, 1990	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K897161	COULTER URIC ACID REAGENT	Mar 01, 1990	Substantially Equivalent	COULTER ELECTRONICS, INC.
K896954	ABBOTT SPECTRUM URIC ACID REAGENT KIT	Feb 23, 1990	Substantially Equivalent	ABBOTT LABORATORIES
K896521	MODIFIED PARAMAX URIC ACID REAGENT	Feb 16, 1990	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K896227	COBAS READY URIC ACID REAGENT	Feb 16, 1990	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K895821	URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS	Dec 05, 1989	Substantially Equivalent	CATACHEM, INC.
K895665	URIC ACID PAP	Oct 23, 1989	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K894101	ROCHE REAGENT FOR URIC ACID	Sep 05, 1989	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K894287	URIC ACID TEST ITEM NUMBER 65422	Aug 28, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K893416	URIC ACID REAGENT (PROCEDURE NUMBER 686)	Jun 23, 1989	Substantially Equivalent	SIGMA CHEMICAL CO.
K892395	AMRESCO URIC ACID REAGENTS #7628	May 24, 1989	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K890319	URIC ACID KIT, CODES 4825400 AND 4825050	Apr 12, 1989	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K884704	URIC ACID TEST (URIC) ITEM #65620	Jan 23, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K883428	BIOTROL URIC ACID ENZYMATIQUE TRINDER	Sep 13, 1988	Substantially Equivalent	BIOTROL, USA, INC.
K883404	URIC ACID REAGENT (PRODUCT #88219)	Sep 13, 1988	Substantially Equivalent	HICHEM DIAGNOSTICS
K880277	URIC ACID REAGENT SET	Apr 18, 1988	Substantially Equivalent	TECH-NEAL SCIENTIFIC, INC.
K880731	WAKO AUTOKIT URIC ACID	Mar 24, 1988	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K873456	PARAMAX URIC ACID REAGENT	Nov 23, 1987	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K873363	URIC ACID PAP	Oct 19, 1987	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K871892	TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER	Jun 17, 1987	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K871902	THE URIC ACID REAGENT SET	Jun 03, 1987	Substantially Equivalent	MACOMB BIOTECHNOLOGY, INC.
K871417	COLORIMETRIC URIC ACID REAGENT SET	Apr 22, 1987	Substantially Equivalent	BIOCHEMICAL TRADE, INC.
K870868	EASY-TEST URIC ACID (URIC) #16606	Mar 19, 1987	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K870632	FAST URIC ACID	Mar 13, 1987	Substantially Equivalent	SCLAVO, INC.
K864341	IQ URIC ACID TEST	Dec 16, 1986	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K863924	URIC ACID	Nov 24, 1986	Substantially Equivalent	TECH-CO, INC.
K864119	URIC ACID TEST	Oct 29, 1986	Substantially Equivalent	U. S. DIAGNOSTICS, INC.
K863251	URIC ACID PROCEDURE	Sep 26, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K863113	URICMETER	Sep 09, 1986	Substantially Equivalent	J. D. ASSOC.
K861831	REFLOTRON URIC ACID	Jul 11, 1986	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K862208	KING DIAGNOSTICS URIC ACID TEST	Jul 08, 1986	Substantially Equivalent	KING DIAGNOSTICS, INC.
K861660	URIC ACID PROCEDURE	Jun 13, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K860732	ENZYMATIC URIC ACID REAGENT	Apr 16, 1986	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K860916	EASY-TEST URIC ACID (URIC), #67516/93	Apr 07, 1986	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K860477	URIC ACID REAGNET SET (TRINDER)	Apr 03, 1986	Substantially Equivalent	STERLING DIAGNOSTICS, INC.
K854185	IN-VITRO TEST DETERMINATION OF URIC ACID	Nov 25, 1985	Substantially Equivalent	CLINICAL DATA, INC.
K853825	URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS	Sep 30, 1985	Substantially Equivalent	CATACHEM, INC.
K853357	URIC ACID REAGENT	Aug 19, 1985	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K852004	UA(URICASE) REAGENT	May 29, 1985	Substantially Equivalent	ALPKEM CORP.
K851991	UN(UREASE)REAGENT UN(A-KETO)REAGENT	May 29, 1985	Substantially Equivalent	ALPKEM CORP.
K844011	FOCUS URIC ACID	Oct 30, 1984	Substantially Equivalent	ABBOTT LABORATORIES
K843938	LINEAR ENZYMATIC URIC ACID SYSTEM	Oct 30, 1984	Substantially Equivalent	SIMMLER, INC.
K843325	SYSTEMATE URIC ACID, HEM 67220	Sep 13, 1984	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K842442	AXIOM STABLE II URIC ACID TEST	Aug 16, 1984	Substantially Equivalent	AXIOM, INC.
K842103	TOYO JOZO URIC ACID TEST	Aug 12, 1984	Substantially Equivalent	ADVOCACY INTERNATIONAL, LTD.
K842246	URIC ACID ASSAY KIT	Jul 18, 1984	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K841702	TDX REA URIC ACID	May 31, 1984	Substantially Equivalent	ABBOTT LABORATORIES
K841049	URIC ACID REAGENT SET ENZYMATIC	May 01, 1984	Substantially Equivalent	MEDICAL SPECIALTIES, INC.
K840781	URIC ACID REAGENT	Apr 13, 1984	Substantially Equivalent	AMERICAN DADE
K834045	URIC ACID REAGENT SET	Jan 30, 1984	Substantially Equivalent	STERLING BIOCHEMICAL, INC.
K832785	COMPUR* EASY TOUCH URIC ACID REAGENT	Oct 14, 1983	Substantially Equivalent	WORTHINGTON DIAGNOSTIC SYSTEMS
K831983	DATA-ZYME URIC ACID PROCEDURE	Aug 08, 1983	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K831864	URIC-ACID TEST ENZYMATIC COLORIMETRIC	Jul 22, 1983	Substantially Equivalent	STANBIO LABORATORY
K831398	LINEAR ENZMATIC URIC ACID SYSTEM	Jun 08, 1983	Substantially Equivalent	SIMMLER, INC.
K830679	URIC ACID COLORIMETRIC DETERMINATION	Apr 06, 1983	Substantially Equivalent	DOW INSTRUMENTS & REAGENTS, INC.
K823846	URIC ACID TEST	Jan 24, 1983	Substantially Equivalent	SCALAVO, INC.
K822913	URIC ACID REAGENT	Dec 20, 1982	Substantially Equivalent	AC BIOCHEMICAL LABORATORIES, INC.
K821812	BECKMAN URIC ACID REAGENT	Jul 02, 1982	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K821741	URICACID	Jul 02, 1982	Substantially Equivalent	BIODYNAMICS CORP.
K821214	URIC ACID REAGENT SET(ENZYMATIC	May 21, 1982	Substantially Equivalent	OMEGA MEDICAL ELECTRONICS
K820632	COLORIMETRIC URIC ACID REAGENT SET	Mar 25, 1982	Substantially Equivalent	BIORENT DIAGNOSTIC, INC.
K813511	URIC-ACID	Dec 31, 1981	Substantially Equivalent	MEDICAL ANALYSIS SYSTEMS, INC.
K812978	URIC ACID SYSTEM PACK TEST	Nov 06, 1981	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K812700	URICAR	Nov 05, 1981	Substantially Equivalent	HI CHEM, INC.
K812641	URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM	Oct 02, 1981	Substantially Equivalent	REAGENTS APPLICATIONS, INC.
K812430	URIC ACID REAGENT SET	Sep 09, 1981	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K811810	URIC ACID TEST	Jul 15, 1981	Substantially Equivalent	ENVIRONMENTAL CHEMICAL SPECIALTIES
K811857	SELECT-A-FLOW	Jul 10, 1981	Substantially Equivalent	WENMAR INTL. CORP.
K811687	URIC ACID TEST	Jul 01, 1981	Substantially Equivalent	KING DIAGNOSTICS, INC.
K811504	WAKO URIC ACID B TEST	Jun 09, 1981	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K810136	URIC ACID REAGENT SYSTEM	Feb 02, 1981	Substantially Equivalent	AMERICAN MONITOR CORP.
K802724	AMES SERA-PAK URIC ACID REAGENT KIT	Dec 10, 1980	Substantially Equivalent	MILES LABORATORIES, INC.
K802692	LANCER URIC ACID AUTO/STAT KIT	Dec 10, 1980	Substantially Equivalent	SHERWOOD MEDICAL CO.
K801898	URIC ACID DIAGNOSTIC REAGENT	Oct 10, 1980	Substantially Equivalent	CONNECTICUT DIAGNOSTICS, LTD.
K801649	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES	Aug 20, 1980	Substantially Equivalent	EASTMAN KODAK COMPANY
K800848	SERALYZER URIC ACID REAGENT STRIPS -	Apr 24, 1980	Substantially Equivalent	MILES LABORATORIES, INC.
K792545	URIC ACID KIT	Jan 29, 1980	Substantially Equivalent	ALTA DIAGNOSTICS, INC.
K791754	URIC ACID REAGENT	Sep 27, 1979	Substantially Equivalent	GILFORD DIAGNOSTICS
K791197	URIDROP SPECIAL	Jul 30, 1979	Substantially Equivalent	AB MEDETT PRODUKTER
K790486	FLOZYME* URIC ACID REAGENT	Apr 23, 1979	Substantially Equivalent	WORTHINGTON DIAGNOSTIC SYSTEMS
K790092	URIC ACID, BOUND ENZYME	Mar 12, 1979	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K781004	HMA URIC ACID TEST	Jul 27, 1978	Substantially Equivalent	HYCEL, INC.
K780827	URIC ACID RAPID STAT KIT	Jun 13, 1978	Substantially Equivalent	PIERCE CHEMICAL CO.
K771088	UNIPAK URIC ACID	Jul 21, 1977	Substantially Equivalent	HARLECO
K770272	URIC ACID TEST, BMC AUTOFLO	Mar 01, 1977	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.

FEI Numbers

This FDA classification entry is associated with 53 FEI numbers. Click on an entry to view related FDA registrations.

1000122044: 23 registrations

1000135102: 101 registrations

1000136573: 169 registrations

1000206808: 104 registrations

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1181121: 182 registrations

1220972: 44 registrations

1616487: 87 registrations

1827821: 149 registrations

1832216: 187 registrations

2050010: 124 registrations

2050012: 131 registrations

2250051: 152 registrations

2432235: 462 registrations

2517506: 354 registrations

2939693: 17 registrations

3000148879: 72 registrations

3000215862: 96 registrations

3000308930: 136 registrations

3002642396: 139 registrations

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3002806560: 8 registrations

3002806809: 96 registrations

3002809144: 150 registrations

3003071743: 72 registrations

3003593973: 38 registrations

3003741796: 84 registrations

3003795116: 46 registrations

3004493545: 205 registrations

3005094123: 56 registrations

3005146313: 63 registrations

3005333358: 273 registrations

3005841640: 8 registrations

3006198300: 142 registrations

3006716639: 13 registrations

3006798115: 20 registrations

3007301207: 16 registrations

3007407790: 7 registrations

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3008987086: 25 registrations

3012963943: 138 registrations

3013352333: 30 registrations

3013660430: 64 registrations

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3018771894: 23 registrations

3021010433: 23 registrations

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5864: 44 registrations