FDA 510(k) Applications for Medical Device Product Code "KNK"
(Acid, Uric, Uricase (Colorimetric))

FDA 510(k) Number Applicant Device Name Decision Date
K991247 A.P. TOTAL CARE, INC. URIC ACID, MODEL UA112-01 05/25/1999
K102568 ABBOTT LABORATORIES URIC ACID MODEL 3P39 05/06/2011
K022096 BAYER DIAGNOSTICS CORP. URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM 03/18/2003
K970919 BECKMAN INSTRUMENTS, INC. SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT 05/21/1997
K981604 CARESIDE, INC. CARESIDE URIC ACID 06/25/1998
K971133 CAROLINA LIQUID CHEMISTRIES CORP. URIC, UA, OR URIC ACID 04/14/1997
K031044 CLINICAL DATA, INC. ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR 07/15/2003
K040467 CLINICAL DATA, INC. VITALAB URIC ACID REAGENT 03/08/2004
K970867 DERMA MEDIA LAB., INC. URIC ACID REAGENT 04/21/1997
K955496 DIAGNOSTIC CHEMICALS LTD. URIC ACID CATALOGE# 220-93/94/97 02/23/1996
K961586 DIAGNOSTIC CHEMICALS LTD. URIC ACID-SL ASSAY CATALOGUE NO. 237-60 07/23/1996
K012038 JAS Diagnostics, Inc. JAS URIC ACID LIQUID REAGENT 08/21/2001
K062862 OLYMPUS AMERICA, INC. OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 04/06/2007
K970560 POINTE SCIENTIFIC, INC. URIC ACID (LIQUID) REAGENT SET 03/11/1997
K993469 WAKO CHEMICALS, USA, INC. WAKO L-TYPE UA F TEST 11/09/1999
K023550 WIENER LABORATORIES S.A.I.C. WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA 12/09/2002
K010421 WIENER LABORATORIES S.A.I.C. WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 04/13/2001


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