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 Roche Diagnostic Systems, 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 May 21, 1997
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
K970919
Beckman Instruments, Inc.
Chemistry · 70d
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 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 Jun 26, 1990
COBAS READY PROFILE 2 REAGENT STRIP
K896225
Roche Diagnostic Systems, Inc.
Chemistry · 239d
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 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 Jan 23, 1989
URIC ACID TEST (URIC) ITEM #65620
K884704
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Nov 23, 1987
PARAMAX URIC ACID REAGENT
K873456
Baxter Healthcare Corp
Chemistry · 87d
Cleared Oct 19, 1987
URIC ACID PAP
K873363
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Mar 19, 1987
EASY-TEST URIC ACID (URIC) #16606
K870868
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Dec 16, 1986
IQ URIC ACID TEST
K864341
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 42d
Cleared Jul 11, 1986
REFLOTRON URIC ACID
K861831
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Apr 07, 1986
EASY-TEST URIC ACID (URIC), #67516/93
K860916
Em Diagnostic Systems, Inc.
Chemistry · 27d
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 May 31, 1984
TDX REA URIC ACID
K841702
Abbott Laboratories
Chemistry · 38d

About Product Code KNK - Regulatory Context