FDA 510(k) Applications for Medical Device Product Code "CDQ"
(Urease And Glutamic Dehydrogenase, Urea Nitrogen)

FDA 510(k) Number Applicant Device Name Decision Date
K990980 A.P. TOTAL CARE, INC. BUN, MODEL BU 104-01 05/25/1999
K810794 ABBOTT LABORATORIES A-GENT UREA NITROGEN 04/01/1981
K844755 ABBOTT LABORATORIES FOCUS UREA NITROGEN 01/08/1985
K853677 ABBOTT LABORATORIES TDX REA BUN 09/16/1985
K981918 ABBOTT LABORATORIES UREA 07/28/1998
K840785 AMERICAN DADE PARAMAX UREA NITROGEN REAGENT 04/05/1984
K852292 AMERICAN MONITOR CORP. DURAZYME UREA NITROGEN 07/08/1985
K892331 AMERICAN MONITOR CORP. ENZYMATIC UREA NITROGEN REAGENT SET 06/20/1989
K900394 AMERICAN RESEARCH PRODUCTS CO. AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 04/11/1990
K891912 AMERICAN RESEARCH PRODUCTS CO. AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 06/19/1989
K942984 AMERICAN RESEARCH PRODUCTS CO. BUN REAGENT 03/01/1995
K831625 AMERICAN SCIENTIFIC PRODUCTS UREA NITROGEN-BUN-REAGENTS B6360-12 07/07/1983
K831626 AMERICAN SCIENTIFIC PRODUCTS UREA NITROGEN-BUN-REAGENTS B6370-11A 07/07/1983
K830555 AMRESCO, INC. AMRESCO UREA NITROGEN REAGENT SET 03/24/1983
K873532 BAXTER HEALTHCARE CORP. PARAMAX UREA NITROGEN REAGENT 11/23/1987
K770654 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC UN, UV DELTA TEST ASSAY 06/24/1977
K761261 BECKMAN INSTRUMENTS, INC. ENZYMATIC BUN (RATE) REAGENT KIT 12/29/1976
K760414 BECKMAN INSTRUMENTS, INC. ENZYMATIC BUN REAGENT KIT 11/05/1976
K851513 BIO-ANALYTICS LABORATORIES, INC. ULTRA-VIOLET BUN REAGENT KIT 05/20/1985
K871547 BIOCHEMICAL TRADE, INC. ULTRA-VIOLET BUN REAGENT KIT (RATE) 06/22/1987
K905602 BIOTOPE, INC. ECLIPSE ICA BUN 01/16/1991
K881366 BIOTROL, USA, INC. BIOTROL BUN ENZYMATIQUE UV H.P. 05/16/1988
K881677 BOEHRINGER MANNHEIM CORP. BUN (KINETIC) 06/07/1988
K895666 BOEHRINGER MANNHEIM CORP. BUN (KINETIC) 10/27/1989
K771923 BOEHRINGER MANNHEIM CORP. FASTCHEM BUN 11/11/1977
K812290 BOEHRINGER MANNHEIM CORP. FUN-UV SYSTEM PACK TEST 08/31/1981
K971967 CAROLINA LIQUID CHEMISTRIES CORP. BUN 06/17/1997
K894173 CATACHEM, INC. BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT 09/05/1989
K902175 COULTER CORP. COULTER UREA NITROGEN REAGENT 06/12/1990
K894836 COULTER ELECTRONICS, INC. DART UREA NITROGEN 10/30/1989
K861666 DATA MEDICAL ASSOCIATES, INC. BLOOD UREA NITROGEN (BUN) PROCEDURE 07/01/1986
K863260 DATA MEDICAL ASSOCIATES, INC. BLOOD UREA NITROGEN(BUN) PROCEDURE 09/09/1986
K802061 DATA MEDICAL ASSOCIATES, INC. DATA-ZYME UREA NITROGEN REAGENT SET 09/26/1980
K971309 DERMA MEDIA LAB., INC. UREA 08/01/1997
K993178 DIAGNOSTIC CHEMICALS LTD. UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 10/18/1999
K002694 DIAGNOSTIC CHEMICALS LTD. UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 09/15/2000
K973931 DIAGNOSTIC CHEMICALS LTD. UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 11/24/1997
K842242 DIAGNOSTIC CHEMICALS, LTD. (USA) UREA ASSAY KIT 07/18/1984
K843057 DIAGNOSTIC CHEMICALS, LTD. (USA) UREA ASSAY KIT 08/27/1984
K853102 DIAGNOSTIC CHEMICALS, LTD. (USA) UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN 08/02/1985
K021385 ELAN DIAGNOSTICS ATAC PAK BUN REAGENT 07/12/2002
K000958 ELAN HOLDINGS, INC. ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS 05/24/2000
K960115 ELAN PHARMA, INC. HICHEM BUN/UREA REAGENT KIT 03/29/1996
K844065 ELECTRO-NUCLEONICS LABORATORIES, INC. ENI BLOOD UREA NITROGEN REAGENT 11/27/1984
K860135 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST UREA (BUN) REAGENT 02/21/1986
K874477 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010 11/23/1987
K870571 EM DIAGNOSTIC SYSTEMS, INC. EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 03/04/1987
K843326 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE BUN HEM NO. 67221 09/14/1984
K903334 EM DIAGNOSTIC SYSTEMS, INC. UREA NITROGEN TEST 09/07/1990
K925002 EM DIAGNOSTIC SYSTEMS, INC. UREA NITROGEN TEST 01/04/1993
K894378 EM DIAGNOSTIC SYSTEMS, INC. UREA NITROGEN TEST (BUN) ITEM #65408 08/31/1989
K884987 EM DIAGNOSTIC SYSTEMS, INC. UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022 01/13/1989
K932161 EM DIAGNOSTIC SYSTEMS, INC. UREA NITROGEN TEST ITEM NUMBER 65408 09/08/1993
K823300 EMD CHEMICALS INC. BUN-UN CENTRIFICHUM 500, #65080/81 01/09/1983
K823472 EMD CHEMICALS INC. ULTRA CHEM BAN-UV #65080 & 65081 12/28/1982
K830241 EMD CHEMICALS INC. ULTRA CHEM BUN-UV #65080-65081 04/05/1983
K823402 EMD CHEMICALS INC. ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& 12/26/1982
K980057 EXIGENT DIAGNOSTICS, INC. CARESIDE BUN 02/05/1998
K781782 GILFORD DIAGNOSTICS BUN 01/10/1979
K800341 GILFORD DIAGNOSTICS BUN REAGENT 03/12/1980
K012649 HEMAGEN DIAGNOSTICS, INC. RAICHEM BUN RATE REAGENT 10/15/2001
K041051 HEMAGEN DIAGNOSTICS, INC. RAICHEM BUN RATE REAGENT (LIQUID) 06/30/2004
K923035 HERAEUS KULZER, INC. MILES URINE UREA NITROGEN METHOD 09/09/1992
K070146 HORIBA ABX ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP 10/12/2007
K934533 HORIZON DIAGNOSTICS, INC. BUN-300/BUN-500 UREA NITROGEN REAGENT 11/26/1993
K770315 ICN PHARMACEUTICALS, INC. BUN, ENZYMATIC 04/05/1977
K974337 INSTRUMENTATION LABORATORY CO. IL TEST UREA NITROGEN 12/17/1997
K914877 INSTRUMENTATION LABORATORY CO. IL TEST(TM) UREA NITROGEN 03/11/1992
K011596 JAS DIAGNOSTIC, INC. UREA NITROGEN (BUN) LIQUID REAGENT 07/17/2001
K800719 MACOMB CHEMICAL CO. ENZYMATIC UREA NITROGEN REAGENT SET REVI 05/08/1980
K780534 MACOMB CHEMICAL CO. UREA NITROGEN (ENZYMATIC) 05/19/1978
K110675 MEDICA CORP. EASYRA UREA NITROGEN AND CREATININE REAGENTS 04/21/2011
K832941 MEDICAL ANALYSIS SYSTEMS, INC. BUN LIQUID STABLE REAGENT SET 10/28/1983
K780069 MEDICAL ANALYSIS SYSTEMS, INC. BUN REAGNET SET 02/14/1978
K952742 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. BLOOD UREA NITROGEN REAGENT SYSTEM 08/11/1995
K944250 OLYMPUS CORP OF AMERICA UREA NITROGEN REAGENT 02/08/1995
K924693 OLYMPUS CORP. OLYMPUS BUN REAGENT 11/25/1992
K931745 OLYMPUS CORP. OLYMPUS REPLY UREA NITROGEN REAGENT 08/19/1993
K922597 OLYMPUS CORP. OLYMPUS UREA NITROGEN (BUN) REAGENT 07/10/1992
K972671 POINTE SCIENTIFIC, INC. BUN (LIQUID) REAGENT SET 07/20/1997
K812341 POINTE SCIENTIFIC, INC. UREA NITROGEN (BUN) 09/01/1981
K024182 PRECISION SYSTEMS, INC. PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS 03/03/2003
K923506 RANDOX LABORATORIES, LTD. UREA KIT 09/27/1993
K812417 REAGENTS APPLICATIONS, INC. BLOOD UREA NITROGEN(BUN-UV) 09/09/1981
K801116 ROCHE ANALYTICAL INSTRUMENTS, INC. COBAS REAGENT FOR BUN 06/17/1980
K954000 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR BUN 10/25/1995
K780943 SCLAVO, INC. BUN TEST UNI-UV BLOOD UREA NITROGEN TEST 07/27/1978
K833931 SERAGEN DIAGNOSTICS, INC. UREA NITROGEN-UV 01/13/1984
K140690 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER 09/02/2014
K821562 SHERWOOD MEDICAL CO. LANCER MSA BUN DIAG. KIT 06/11/1982
K863196 SIGMA DIAGNOSTICS, INC. BUN (RATE) REAGENT 08/26/1986
K850923 SIGMA DIAGNOSTICS, INC. BUN (RATE) REAGENT 03/20/1985
K852131 SIGMA DIAGNOSTICS, INC. BUN(ENDPOINT) REAGENT 06/10/1985
K982236 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT 08/05/1998
K992800 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P 09/28/1999
K962418 STANBIO LABORATORY UREA NITROGEN (BUN) LIQUI-UV 12/26/1996
K840064 STERLING BIOCHEMICAL, INC. UREA NITROGEN REAGENT SET 06/14/1984
K862210 STERLING DIAGNOSTICS, INC. UREA NITROGEN (GLDH) REAGENT SET (UV) 07/01/1986
K911248 SYNERMED, INC. SYNERMED UREA NITROGEN REAGENT KIT 06/03/1991
K863925 TECH-CO, INC. UREA NITROGEN(BUN) 11/24/1986
K880078 TECH-NEAL SCIENTIFIC, INC. UREA NITROGEN (BUN) 02/11/1988
K901123 TECHNICON INSTRUMENTS CORP. CHEM 1 CLINICAL ANALYZER "URINE UREA NITROGEN" 05/10/1990
K860109 TECHNOSTICS INTL. ENZYMATIC UREA NITROGEN REAGENT SET 02/06/1986
K060120 TECO DIAGNOSTICS TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM 03/27/2006
K981106 TECO DIAGNOSTICS UREA NITROGEN (BUN) LIQUID REAGENT 04/16/1998
K073295 THERMO FISHER SCIENTIFIC OY UREA/BUN, SCAL, NORTROL, ABTROL 05/29/2008
K971477 TRACE AMERICA, INC. UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) 05/27/1997
K860716 TRACE SCIENTIFIC LTD. ENZYMATIC BUN REAGENT 04/24/1986
K872484 TRACE SCIENTIFIC LTD. MODIFIED ENZYMATIC BUN REAGENT 08/19/1987
K981123 TRACE SCIENTIFIC LTD. UREA 04/24/1998
K800128 UNION CARBIDE CORP. CENTRIFICHEM BUN 02/13/1980
K800529 UNION CARBIDE CORP. CENTRIFICHEM BUN 03/20/1980
K993925 WAKO CHEMICALS, USA, INC. WAKO L-TYPE UN TEST 04/03/2000
K873335 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT UREA N 10/02/1987
K012260 WIENER LABORATORIES S.A.I.C. WIENER LAB. UREA UV CINETICA AA 09/19/2001
K832749 WORTHINGTON DIAGNOSTIC SYSTEMS EASYTOUCH BUN REAGENT SET 10/14/1983


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