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 |