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

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 Mar 18, 2003
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022096
Bayer Diagnostics Corp.
Chemistry · 264d
Cleared Dec 09, 2002
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
K023550
Wiener Laboratories Saic
Chemistry · 48d
Cleared Aug 21, 2001
JAS URIC ACID LIQUID REAGENT
K012038
Jas Diagnostics, Inc.
Chemistry · 53d
Cleared Apr 13, 2001
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
K010421
Wiener Laboratories Saic
Chemistry · 60d
Cleared Nov 09, 1999
WAKO L-TYPE UA F TEST
K993469
Wako Chemicals USA, Inc.
Chemistry · 27d
Cleared May 25, 1999
URIC ACID, MODEL UA112-01
K991247
A.P. Total Care, Inc.
Chemistry · 43d
Cleared Jun 25, 1998
CARESIDE URIC ACID
K981604
Careside, Inc.
Chemistry · 58d
Cleared May 21, 1997
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
K970919
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Apr 21, 1997
URIC ACID REAGENT
K970867
Derma Media Lab., Inc.
Chemistry · 42d
Cleared Apr 14, 1997
URIC, UA, OR URIC ACID
K971133
Carolina Liquid Chemistries Corp.
Chemistry · 18d
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 Dec 02, 1994
URIC ACID QVET
K943002
Prisma Systems
Chemistry · 162d
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

About Product Code KNK - Regulatory Context