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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
