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Panels › Clinical Chemistry › Product code CDQ · Class 2

Urease And Glutamic Dehydrogenase, Urea Nitrogen

Regulation 862.1770

0510(k)s in 12 months (117 all time)
0recalls in 12 months (6 all time)
4recalls that name a 510(k)
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Top companies in CDQ

Company510(k)sRecalls
Em Diagnostic Systems, Inc.90
Diagnostic Chemicals , Ltd.60
Abbott Laboratories41
Sigma Diagnostics, Inc.50
Boehringer Mannheim Corp.40
Emd Chemicals, Inc.40
American Research Products Co.30
Data Medical Associates, Inc.30
Olympus Corp.30
Siemens Healthcare Diagnostics, Inc.03
Decided510(k)Device and applicantCode
Aug 31, 1981K812290FUN-UV SYSTEM PACK TEST
Boehringer Mannheim Corp.
CDQ
Apr 1, 1981K810794A-GENT UREA NITROGEN
Abbott Laboratories
CDQ
Sep 26, 1980K802061DATA-ZYME UREA NITROGEN REAGENT SET
Data Medical Associates, Inc.
CDQ
Jun 17, 1980K801116COBAS REAGENT FOR BUN
Roche Analytical Instruments, Inc.
CDQ
May 8, 1980K800719ENZYMATIC UREA NITROGEN REAGENT SET REVI
Macomb Chemical Co.
CDQ
Mar 20, 1980K800529CENTRIFICHEM BUN
Union Carbide Corp.
CDQ
Mar 12, 1980K800341BUN REAGENT
Gilford Diagnostics
CDQ
Feb 13, 1980K800128CENTRIFICHEM BUN
Union Carbide Corp.
CDQ
Jan 10, 1979K781782BUN
Gilford Diagnostics
CDQ
Jul 27, 1978K780943BUN TEST UNI-UV BLOOD UREA NITROGEN TEST
Sclavo, Inc.
CDQ
May 19, 1978K780534UREA NITROGEN (ENZYMATIC)
Macomb Chemical Co.
CDQ
Feb 14, 1978K780069BUN REAGNET SET
Medical Analysis Systems, Inc.
CDQ
Nov 11, 1977K771923FASTCHEM BUN
Boehringer Mannheim Corp.
CDQ
Jun 24, 1977K770654UN, UV DELTA TEST ASSAY
Bd Becton Dickinson Vacutainer Systems Preanalytic
CDQ
Apr 5, 1977K770315BUN, ENZYMATIC
Icn Pharmaceuticals, Inc.
CDQ
Dec 29, 1976K761261ENZYMATIC BUN (RATE) REAGENT KIT
Beckman Instruments, Inc.
CDQ
Nov 5, 1976K760414ENZYMATIC BUN REAGENT KIT
Beckman Instruments, Inc.
CDQ

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