KNK · Class I · 21 CFR 862.1775

FDA Product Code KNK: Acid, Uric, Uricase (colorimetric)

Leading manufacturers include Em Diagnostic Systems, Inc., Boehringer Mannheim Corp. and Wako Chemicals USA, Inc..

118
Total
118
Cleared
59d
Avg days
1977
Since
118 devices
73–96 of 118
Cleared May 29, 1985
UA(URICASE) REAGENT
K852004
Alpkem Corp.
Chemistry · 22d
Cleared Oct 30, 1984
LINEAR ENZYMATIC URIC ACID SYSTEM
K843938
Simmler, Inc.
Chemistry · 21d
Cleared Oct 30, 1984
FOCUS URIC ACID
K844011
Abbott Laboratories
Chemistry · 18d
Cleared Sep 13, 1984
SYSTEMATE URIC ACID, HEM 67220
K843325
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 16, 1984
AXIOM STABLE II URIC ACID TEST
K842442
Axiom, Inc.
Chemistry · 56d
Cleared Aug 12, 1984
TOYO JOZO URIC ACID TEST
K842103
Advocacy International, Ltd.
Chemistry · 79d
Cleared Jul 18, 1984
URIC ACID ASSAY KIT
K842246
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared May 31, 1984
TDX REA URIC ACID
K841702
Abbott Laboratories
Chemistry · 38d
Cleared May 01, 1984
URIC ACID REAGENT SET ENZYMATIC
K841049
Medical Specialties, Inc.
Chemistry · 50d
Cleared Apr 13, 1984
URIC ACID REAGENT
K840781
American Dade
Chemistry · 65d
Cleared Jan 30, 1984
URIC ACID REAGENT SET
K834045
Sterling Biochemical, Inc.
Chemistry · 68d
Cleared Oct 14, 1983
COMPUR* EASY TOUCH URIC ACID REAGENT
K832785
Worthington Diagnostic Systems
Chemistry · 59d
Cleared Aug 08, 1983
DATA-ZYME URIC ACID PROCEDURE
K831983
Data Medical Associates, Inc.
Chemistry · 49d
Cleared Jul 22, 1983
URIC-ACID TEST ENZYMATIC COLORIMETRIC
K831864
Stanbio Laboratory
Chemistry · 42d
Cleared Jun 08, 1983
LINEAR ENZMATIC URIC ACID SYSTEM
K831398
Simmler, Inc.
Chemistry · 40d
Cleared Apr 06, 1983
URIC ACID COLORIMETRIC DETERMINATION
K830679
Dow Instruments & Reagents, Inc.
Chemistry · 33d
Cleared Jan 24, 1983
URIC ACID TEST
K823846
Scalavo, Inc.
Chemistry · 34d
Cleared Dec 20, 1982
URIC ACID REAGENT
K822913
Ac Biochemical Laboratories, Inc.
Chemistry · 80d
Cleared Jul 02, 1982
URICACID
K821741
Biodynamics Corp.
Chemistry · 18d
Cleared Jul 02, 1982
BECKMAN URIC ACID REAGENT
K821812
Beckman Instruments, Inc.
Chemistry · 14d
Cleared May 21, 1982
URIC ACID REAGENT SET(ENZYMATIC
K821214
Omega Medical Electronics
Chemistry · 24d
Cleared Mar 25, 1982
COLORIMETRIC URIC ACID REAGENT SET
K820632
Biorent Diagnostic, Inc.
Chemistry · 17d
Cleared Dec 31, 1981
URIC-ACID
K813511
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Nov 06, 1981
URIC ACID SYSTEM PACK TEST
K812978
Boehringer Mannheim Corp.
Chemistry · 14d