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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
Oct 30, 1989K894836DART UREA NITROGEN
Coulter Electronics, Inc.
CDQ
Oct 27, 1989K895666BUN (KINETIC)
Boehringer Mannheim Corp.
CDQ
Sep 5, 1989K894173BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT
Catachem, Inc.
CDQ
Aug 31, 1989K894378UREA NITROGEN TEST (BUN) ITEM #65408
Em Diagnostic Systems, Inc.
CDQ
Jun 20, 1989K892331ENZYMATIC UREA NITROGEN REAGENT SET
American Monitor Corp.
CDQ
Jun 19, 1989K891912AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123
American Research Products Co.
CDQ
Jan 13, 1989K884987UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
Em Diagnostic Systems, Inc.
CDQ
Jun 7, 1988K881677BUN (KINETIC)
Boehringer Mannheim Corp.
CDQ
May 16, 1988K881366BIOTROL BUN ENZYMATIQUE UV H.P.
Biotrol, USA, Inc.
CDQ
Feb 11, 1988K880078UREA NITROGEN (BUN)
Tech-Neal Scientific, Inc.
CDQ
Nov 23, 1987K874477EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010
Em Diagnostic Systems, Inc.
CDQ
Nov 23, 1987K873532PARAMAX UREA NITROGEN REAGENT
Baxter Healthcare Corp
CDQ
Oct 2, 1987K873335WAKO(TM) AUTOKIT UREA N
Wako Chemicals USA, Inc.
CDQ
Aug 19, 1987K872484MODIFIED ENZYMATIC BUN REAGENT
Trace Scientific , Ltd.
CDQ
Jun 22, 1987K871547ULTRA-VIOLET BUN REAGENT KIT (RATE)
Biochemical Trade, Inc.
CDQ
Mar 4, 1987K870571EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
Em Diagnostic Systems, Inc.
CDQ
Nov 24, 1986K863925UREA NITROGEN(BUN)
Tech-Co, Inc.
CDQ
Sep 9, 1986K863260BLOOD UREA NITROGEN(BUN) PROCEDURE
Data Medical Associates, Inc.
CDQ
Aug 26, 1986K863196BUN (RATE) REAGENT
Sigma Diagnostics, Inc.
CDQ
Jul 1, 1986K862210UREA NITROGEN (GLDH) REAGENT SET (UV)
Sterling Diagnostics, Inc.
CDQ
Jul 1, 1986K861666BLOOD UREA NITROGEN (BUN) PROCEDURE
Data Medical Associates, Inc.
CDQ
Apr 24, 1986K860716ENZYMATIC BUN REAGENT
Trace Scientific , Ltd., AU
CDQ
Feb 21, 1986K860135EASY-TEST UREA (BUN) REAGENT
Em Diagnostic Systems, Inc.
CDQ
Feb 6, 1986K860109ENZYMATIC UREA NITROGEN REAGENT SET
Technostics Intl.
CDQ
Sep 16, 1985K853677TDX REA BUN
Abbott Laboratories
CDQ
Aug 2, 1985K853102UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN
Diagnostic Chemicals, Ltd. (Usa), CA
CDQ
Jul 8, 1985K852292DURAZYME UREA NITROGEN
American Monitor Corp.
CDQ
Jun 10, 1985K852131BUN(ENDPOINT) REAGENT
Sigma Diagnostics, Inc.
CDQ
May 20, 1985K851513ULTRA-VIOLET BUN REAGENT KIT
Bio-Analytics Laboratories, Inc.
CDQ
Mar 20, 1985K850923BUN (RATE) REAGENT
Sigma Diagnostics, Inc.
CDQ
Jan 8, 1985K844755FOCUS UREA NITROGEN
Abbott Laboratories
CDQ
Nov 27, 1984K844065ENI BLOOD UREA NITROGEN REAGENT
Electro-Nucleonics Laboratories, Inc.
CDQ
Sep 14, 1984K843326SYSTEMATE BUN HEM NO. 67221
Em Diagnostic Systems, Inc.
CDQ
Aug 27, 1984K843057UREA ASSAY KIT
Diagnostic Chemicals, Ltd. (Usa)
CDQ
Jul 18, 1984K842242UREA ASSAY KIT
Diagnostic Chemicals, Ltd. (Usa)
CDQ
Jun 14, 1984K840064UREA NITROGEN REAGENT SET
Sterling Biochemical, Inc.
CDQ
Apr 5, 1984K840785PARAMAX UREA NITROGEN REAGENT
American Dade
CDQ
Jan 13, 1984K833931UREA NITROGEN-UV
Seragen Diagnostics, Inc.
CDQ
Oct 28, 1983K832941BUN LIQUID STABLE REAGENT SET
Medical Analysis Systems, Inc.
CDQ
Oct 14, 1983K832749EASYTOUCH BUN REAGENT SET
Worthington Diagnostic Systems
CDQ
Jul 7, 1983K831626UREA NITROGEN-BUN-REAGENTS B6370-11A
American Scientific Products
CDQ
Jul 7, 1983K831625UREA NITROGEN-BUN-REAGENTS B6360-12
American Scientific Products
CDQ
Apr 5, 1983K830241ULTRA CHEM BUN-UV #65080-65081
Emd Chemicals, Inc.
CDQ
Mar 24, 1983K830555AMRESCO UREA NITROGEN REAGENT SET
Amresco, Inc.
CDQ
Jan 9, 1983K823300BUN-UN CENTRIFICHUM 500, #65080/81
Emd Chemicals, Inc.
CDQ
Dec 28, 1982K823472ULTRA CHEM BAN-UV #65080 & 65081
Emd Chemicals, Inc.
CDQ
Dec 26, 1982K823402ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&
Emd Chemicals, Inc.
CDQ
Jun 11, 1982K821562LANCER MSA BUN DIAG. KIT
Sherwood Medical Co.
CDQ
Sep 9, 1981K812417BLOOD UREA NITROGEN(BUN-UV)
Reagents Applications, Inc.
CDQ
Sep 1, 1981K812341UREA NITROGEN (BUN)
Pointe Scientific, Inc.,
CDQ

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