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
K955752 OLYMPUS AMERICA, INC. OLYMPUS URIC ACID REAGENT 01/31/1996
K033278 RANDOX LABORATORIES, LTD. RANDOX URIC ACID 02/27/2004
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
K971485 TRACE AMERICA, INC. URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) 05/27/1997


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