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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