CDO · Class I · 21 CFR 862.1775

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

Leading manufacturers include Em Diagnostic Systems, Inc., Emd Chemicals, Inc. and Abbott Laboratories.

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 Feb 27, 2004
RANDOX URIC ACID
K033278
Randox Laboratories, Ltd.
Chemistry · 140d
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 Jan 31, 1996
OLYMPUS URIC ACID REAGENT
K955752
Olympus America, Inc.
Chemistry · 43d
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 Feb 01, 1988
BIOTROL URIC ACID ENZYMATIQUE UV H.P.
K875320
Biotrol, USA, Inc.
Chemistry · 34d
Cleared Sep 11, 1987
GEMENI URIC ACID U.V.
K873358
Electro-Nucleonics Laboratories, Inc.
Chemistry · 21d
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 27, 1982
URIC ACID 75CDO
K822884
Technicon Instruments Corp.
Chemistry · 29d
Cleared Jun 03, 1982
ULTRACHEM URIC ACID AIDH #65047
K821474
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 02, 1982
ULTRACHEM URIC ACID AIDH, #65047
K821465
Emd Chemicals, Inc.
Chemistry · 15d
Cleared May 14, 1982
URICASE (U.V.) URIC ACID
K821167
Syn-Kit, Inc.
Chemistry · 17d
Cleared Sep 23, 1981
ULTRACHEM URIC ACID ALDH, ITEM #65047
K812500
Harleco
Chemistry · 23d
Cleared Oct 23, 1980
URIC ACID/ALDH
K802371
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Feb 13, 1980
CENTRIFICHEM URIC ACID
K800130
Union Carbide Corp.
Chemistry · 26d
Cleared Jan 03, 1979
ACID REAGENT, URIC SINGLE VIAL
K781996
Calbiochem-Behring Corp.
Chemistry · 35d
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
Cleared Jul 05, 1977
IN VITRO DIAG. FOR URIC ACID
K770767
Smithkline Diagnostics, Inc.
Chemistry · 68d

About Product Code CDO - Regulatory Context