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
118 devices
49–72 of 118
Cleared Apr 16, 1986
ENZYMATIC URIC ACID REAGENT
K860732
Trace Scientific , Ltd.
Chemistry · 49d
Cleared Apr 07, 1986
EASY-TEST URIC ACID (URIC), #67516/93
K860916
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 03, 1986
URIC ACID REAGNET SET (TRINDER)
K860477
Sterling Diagnostics, Inc.
Chemistry · 55d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF URIC ACID
K854185
Clinical Data, Inc.
Chemistry · 41d
Cleared Sep 30, 1985
URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS
K853825
Catachem, Inc.
Chemistry · 17d
Cleared Aug 19, 1985
URIC ACID REAGENT
K853357
Sigma Diagnostics, Inc.
Chemistry · 7d
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 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 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 Jul 02, 1982
BECKMAN URIC ACID REAGENT
K821812
Beckman Instruments, Inc.
Chemistry · 14d
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
Cleared Nov 05, 1981
URICAR
K812700
Hi Chem, Inc.
Chemistry · 43d
Cleared Oct 02, 1981
URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM
K812641
Reagents Applications, Inc.
Chemistry · 16d
Cleared Sep 09, 1981
URIC ACID REAGENT SET
K812430
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Jul 01, 1981
URIC ACID TEST
K811687
King Diagnostics, Inc.
Chemistry · 16d
Cleared Jun 09, 1981
WAKO URIC ACID B TEST
K811504
Wako Chemicals USA, Inc.
Chemistry · 13d
Cleared Feb 02, 1981
URIC ACID REAGENT SYSTEM
K810136
American Monitor Corp.
Chemistry · 12d
Cleared Dec 10, 1980
LANCER URIC ACID AUTO/STAT KIT
K802692
Sherwood Medical Co.
Chemistry · 41d