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 |
K850923 |
SIGMA DIAGNOSTICS, INC. |
BUN (RATE) REAGENT |
03/20/1985 |
K863196 |
SIGMA DIAGNOSTICS, INC. |
BUN (RATE) REAGENT |
08/26/1986 |
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 |