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 Abbott Laboratories.

118
Total
118
Cleared
59d
Avg days
1977
Since

FDA 510(k) Cleared Acid, Uric, Uricase (colorimetric) Devices (Product Code KNK)

118 devices
1–24 of 118
Cleared May 06, 2011
URIC ACID MODEL 3P39
K102568
Abbott Laboratories
Chemistry · 241d
Cleared Apr 06, 2007
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
K062862
Olympus America, Inc.
Chemistry · 193d
Cleared Mar 08, 2004
VITALAB URIC ACID REAGENT
K040467
Clinical Data, Inc.
Chemistry · 13d
Cleared Jul 15, 2003
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
K031044
Clinical Data, Inc.
Toxicology · 105d
Cleared Nov 09, 1999
WAKO L-TYPE UA F TEST
K993469
Wako Chemicals USA, Inc.
Chemistry · 27d
Cleared May 21, 1997
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
K970919
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Mar 11, 1997
URIC ACID (LIQUID) REAGENT SET
K970560
Pointe Scientific, Inc.,
Chemistry · 26d
Cleared Jul 23, 1996
URIC ACID-SL ASSAY CATALOGUE NO. 237-60
K961586
Diagnostic Chemicals , Ltd.
Chemistry · 90d
Cleared Feb 23, 1996
URIC ACID CATALOGE# 220-93/94/97
K955496
Diagnostic Chemicals , Ltd.
Chemistry · 84d
Cleared Apr 25, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
K932728
Eastman Kodak Company
Chemistry · 322d
Cleared Oct 01, 1993
IL TEST URIC ACID
K931350
Instrumentation Laboratory CO
Chemistry · 198d
Cleared Jul 22, 1993
URIC ACID ENZYMATIC COLORIMERIC KIT
K923503
Randox Laboratories, Ltd.
Chemistry · 372d
Cleared Jan 26, 1993
OLYMPUS URIC ACID REAGENT
K925113
Olympus Corp.
Chemistry · 109d
Cleared Sep 22, 1992
SYNERMED 600 NM URIC ACID REAGENT KIT
K923414
Synermed, Inc.
Chemistry · 74d
Cleared Sep 22, 1992
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129
Heraeus Kulzer, Inc.
Chemistry · 36d
Cleared Jul 17, 1992
OLYMPUS URIC ACID REAGENT
K922756
Olympus Corp.
Chemistry · 38d
Cleared Jul 09, 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762
Roche Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Sep 27, 1991
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
K913706
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 27, 1990
SYNERMED URIC ACID REAGENT KIT
K903727
Synermed, Inc.
Chemistry · 42d
Cleared Jun 26, 1990
COBAS READY PROFILE 2 REAGENT STRIP
K896225
Roche Diagnostic Systems, Inc.
Chemistry · 239d
Cleared May 14, 1990
WAKO(TM) AUTOKIT URIC ACID
K901544
Wako Chemicals USA, Inc.
Chemistry · 41d
Cleared Apr 25, 1990
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC
K901693
Technicon Instruments Corp.
Chemistry · 14d
Cleared Mar 01, 1990
COULTER URIC ACID REAGENT
K897161
Coulter Electronics, Inc.
Chemistry · 63d
Cleared Feb 23, 1990
ABBOTT SPECTRUM URIC ACID REAGENT KIT
K896954
Abbott Laboratories
Chemistry · 71d

About Product Code KNK - Regulatory Context