CDO · Class I · 21 CFR 862.1775

FDA Product Code CDO: Acid, Uric, Uricase (u.v.)

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Sigma Diagnostics, Inc..

31
Total
31
Cleared
42d
Avg days
1976
Since

FDA 510(k) Cleared Acid, Uric, Uricase (u.v.) Devices (Product Code CDO)

31 devices
1–24 of 31
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
K992798
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Aug 18, 1998
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
K982251
Sigma Diagnostics, Inc.
Chemistry · 53d
Cleared Jun 19, 1998
URIC ACID
K981766
Abbott Laboratories
Chemistry · 31d
Cleared May 07, 1998
URIC ACID
K981189
Abbott Laboratories
Chemistry · 35d
Cleared Sep 27, 1993
URIC ACID TEST ITEM NUMBER 65422
K932162
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Sep 22, 1992
SYSTEMATE URICACID TEST, TECHNICON RA 1000
K923765
Em Diagnostic Systems, Inc.
Chemistry · 56d
Cleared Aug 17, 1990
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
K903335
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Oct 29, 1986
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
K863660
Em Diagnostic Systems, Inc.
Chemistry · 41d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR URIC ACID
K844986
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Oct 23, 1980
URIC ACID/ALDH
K802371
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Jul 27, 1978
PRINCETON BIOMEDIX URICASE (UV)
K780859
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 64d
Cleared Sep 13, 1977
MULTISTAT III URIC ACID TEST
K771509
Instrumentation Laboratory CO
Chemistry · 39d

About Product Code CDO - Regulatory Context