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
25–48 of 118
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
Cleared Feb 16, 1990
COBAS READY URIC ACID REAGENT
K896227
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
MODIFIED PARAMAX URIC ACID REAGENT
K896521
Baxter Healthcare Corp
Chemistry · 93d
Cleared Dec 05, 1989
URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS
K895821
Catachem, Inc.
Chemistry · 67d
Cleared Oct 23, 1989
URIC ACID PAP
K895665
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Sep 05, 1989
ROCHE REAGENT FOR URIC ACID
K894101
Roche Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 28, 1989
URIC ACID TEST ITEM NUMBER 65422
K894287
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Jun 23, 1989
URIC ACID REAGENT (PROCEDURE NUMBER 686)
K893416
Sigma Chemical Co.
Chemistry · 52d
Cleared May 24, 1989
AMRESCO URIC ACID REAGENTS #7628
K892395
American Research Products Co.
Chemistry · 47d
Cleared Apr 12, 1989
URIC ACID KIT, CODES 4825400 AND 4825050
K890319
American Research Products Co.
Chemistry · 79d
Cleared Jan 23, 1989
URIC ACID TEST (URIC) ITEM #65620
K884704
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Sep 13, 1988
URIC ACID REAGENT (PRODUCT #88219)
K883404
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 13, 1988
BIOTROL URIC ACID ENZYMATIQUE TRINDER
K883428
Biotrol, USA, Inc.
Chemistry · 29d
Cleared Apr 18, 1988
URIC ACID REAGENT SET
K880277
Tech-Neal Scientific, Inc.
Chemistry · 88d
Cleared Mar 24, 1988
WAKO AUTOKIT URIC ACID
K880731
Wako Chemicals USA, Inc.
Chemistry · 29d
Cleared Nov 23, 1987
PARAMAX URIC ACID REAGENT
K873456
Baxter Healthcare Corp
Chemistry · 87d