FDA 510(k) Applications for Medical Device Product Code "CDO"
(Acid, Uric, Uricase (U.V.))

FDA 510(k) Number Applicant Device Name Decision Date
K981189 ABBOTT LABORATORIES URIC ACID 05/07/1998
K981766 ABBOTT LABORATORIES URIC ACID 06/19/1998
K780859 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PRINCETON BIOMEDIX URICASE (UV) 07/27/1978
K813244 BIORENT DIAGNOSTIC, INC. UV URIC ACID DETERMINATION 12/08/1981
K875320 BIOTROL, USA, INC. BIOTROL URIC ACID ENZYMATIQUE UV H.P. 02/01/1988
K802371 BOEHRINGER MANNHEIM CORP. URIC ACID/ALDH 10/23/1980
K781996 CALBIOCHEM-BEHRING CORP. ACID REAGENT, URIC SINGLE VIAL 01/03/1979
K873358 ELECTRO-NUCLEONICS LABORATORIES, INC. GEMENI URIC ACID U.V. 09/11/1987
K863660 EM DIAGNOSTIC SYSTEMS, INC. EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 10/29/1986
K903335 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 08/17/1990
K923765 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE URICACID TEST, TECHNICON RA 1000 09/22/1992
K932162 EM DIAGNOSTIC SYSTEMS, INC. URIC ACID TEST ITEM NUMBER 65422 09/27/1993
K821474 EMD CHEMICALS INC. ULTRACHEM URIC ACID AIDH #65047 06/03/1982
K821465 EMD CHEMICALS INC. ULTRACHEM URIC ACID AIDH, #65047 06/02/1982
K812500 HARLECO ULTRACHEM URIC ACID ALDH, ITEM #65047 09/23/1981
K821872 HARLECO DIAGNOSTICS ULTRACHEM URIC ACID AIDH 07/14/1982
K771509 INSTRUMENTATION LABORATORY CO. MULTISTAT III URIC ACID TEST 09/13/1977
K955752 OLYMPUS AMERICA, INC. OLYMPUS URIC ACID REAGENT 01/31/1996
K033278 RANDOX LABORATORIES, LTD. RANDOX URIC ACID 02/27/2004
K801243 ROCHE ANALYTICAL INSTRUMENTS, INC. COBAS REAGENTS FOR URIC ACID 06/26/1980
K844986 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENTS REAGENT FOR URIC ACID 01/18/1985
K982251 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT 08/18/1998
K992798 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P 09/28/1999
K770767 SMITH KLINE DIAGNOSTICS, INC. IN VITRO DIAG. FOR URIC ACID 07/05/1977
K821167 SYN-KIT, INC. URICASE (U.V.) URIC ACID 05/14/1982
K822884 TECHNICON INSTRUMENTS CORP. URIC ACID 75CDO 10/27/1982
K790834 THE DOW CHEMICAL CO. UV URIC ACID DETERMINATION 06/28/1979
K971485 TRACE AMERICA, INC. URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) 05/27/1997
K800130 UNION CARBIDE CORP. CENTRIFICHEM URIC ACID 02/13/1980
K770831 WORTHINGTON BIOCHEMICAL CORP. STATZYME URIC ACID REAGENT 07/11/1977
K760989 WORTHINGTON BIOCHEMICAL CORP. URIC ACID REAGENT SET 12/09/1976


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