FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K884224 |
A-KEM, INC. |
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS |
12/15/1988 |
K991866 |
A.P. TOTAL CARE, INC. |
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 |
08/02/1999 |
K860424 |
ABBOTT LABORATORIES |
A-GENT LIQUID TOTAL BILIRUBIN |
04/03/1986 |
K880743 |
ABBOTT LABORATORIES |
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT |
04/05/1988 |
K843908 |
ABBOTT LABORATORIES |
ABBOTT TDT EIA |
04/03/1985 |
K121985 |
ABBOTT LABORATORIES |
ARCHITECT TOTAL BILIRUBIN |
02/01/2013 |
K981943 |
ABBOTT LABORATORIES |
DBIL |
07/22/1998 |
K022180 |
ABBOTT LABORATORIES |
DIRECT BILIRUBIN |
09/06/2002 |
K981222 |
ABBOTT LABORATORIES |
DIRECT BILIRUBIN (DBIL) |
04/24/1998 |
K991175 |
ABBOTT LABORATORIES |
MODIFICATION TO ALCYON DIRECT BILIRUBIN |
05/28/1999 |
K981336 |
ABBOTT LABORATORIES |
TBIL |
05/01/1998 |
K983133 |
ABBOTT LABORATORIES |
TBIL |
09/16/1998 |
K022339 |
ABBOTT LABORATORIES |
TOTAL BILIRUBIN |
09/13/2002 |
K150510 |
ABBOTT LABORATORIES |
Total Bilirubin |
04/02/2015 |
K060574 |
ABBOTT LABORATORIES |
TOTAL BILIRUBIN |
05/03/2006 |
K872487 |
ABBOTT LABORATORIES |
VISION(R) TOTAL BILIRUBIN |
08/21/1987 |
K880437 |
ABBOTT LABORATORIES |
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM |
08/03/1988 |
K850379 |
ADVANCED BIOMEDICAL METHODS, INC. |
DIRECT BILIRUBIN FOR DEMAND ANALYZER |
03/01/1985 |
K790608 |
ADVANCED INSTRUMENTS, INC. |
BL BILIRUBINOMETER |
06/15/1979 |
K850748 |
ALLIED INSTRUMENTATION LABORATORY |
I-L TEST, DIRECT BILIRUBIN SET |
04/03/1985 |
K852008 |
ALPKEM CORP. |
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL |
05/30/1985 |
K840777 |
AMERICAN DADE |
DIRECT BILIRUBIN REAGENT |
04/05/1984 |
K840779 |
AMERICAN DADE |
NEONATAL BILIRUBIN REAGENT |
04/13/1984 |
K833004 |
AMERICAN DADE |
PARAMAX TOTAL BILIRUBIN REAGENT |
10/14/1983 |
K802630 |
AMERICAN MONITOR CORP. |
CAFFEINE REAGENT DIAZO COLORIMETRY |
11/26/1980 |
K900571 |
AMERICAN RESEARCH PRODUCTS CO. |
AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) |
04/16/1990 |
K840564 |
AMERICAN RESEARCH PRODUCTS CO. |
LIQUI ZYME TOTAL BILIRUBIN REAGENT |
03/09/1984 |
K871531 |
AMERICAN RESEARCH PRODUCTS CO. |
REAGENTS 1263,1273,1284,1425,014301,053583 |
05/18/1987 |
K871530 |
AMERICAN RESEARCH PRODUCTS CO. |
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583 |
05/14/1987 |
K912733 |
AMERSHAM CORP. |
AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT |
07/22/1991 |
K862299 |
AMRESCO, INC. |
AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS |
07/01/1986 |
K904381 |
AMRESCO, INC. |
DIAZO COLORIMENTRY DIRECT BILIRUBIN |
10/12/1990 |
K904468 |
AMRESCO, INC. |
DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 |
01/17/1991 |
K812841 |
ANCO MEDICAL REAGENTS & ASSOC. |
TOTAL & DIRECT BILIRUBIN REAGENT SET |
11/27/1981 |
K051432 |
ARKRAY, INC. |
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS |
06/17/2005 |
K972382 |
ARROWS CO., LTD. |
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL |
09/14/1998 |
K993867 |
BAYER CORP. |
BAYER ADVIA IMS SYSTEM |
04/10/2000 |
K874261 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
IQ/QCA TOTAL BILIRUBIN |
11/25/1987 |
K812784 |
BECKMAN INSTRUMENTS, INC. |
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD |
10/20/1981 |
K812754 |
BECKMAN INSTRUMENTS, INC. |
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN |
10/19/1981 |
K902801 |
BECKMAN INSTRUMENTS, INC. |
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT |
07/17/1990 |
K934068 |
BECKMAN-DIAGNOSTIC SYSTEMS GROUP |
BECKMAN DIRECT BILIRUBIN REAGENT |
04/26/1994 |
K910635 |
BIOCHEMICAL TRADE, INC. |
TOTAL BILIRUBIN REAGENT SET |
05/15/1991 |
K781921 |
BOEHRINGER MANNHEIM CORP. |
BILIRUBIN, DINGLE VALVE DPD |
01/03/1979 |
K872818 |
BOEHRINGER MANNHEIM CORP. |
REFLOTRON BILIRUBIN |
11/23/1987 |
K981883 |
BOEHRINGER MANNHEIM CORP. |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 |
07/07/1998 |
K993771 |
CARESIDE, INC. |
CARESIDE DIRECT BILIRUBIN |
12/27/1999 |
K981588 |
CARESIDE, INC. |
CARESIDE TOTAL BILIRUBIN |
06/23/1998 |
K972073 |
CAROLINA LIQUID CHEMISTRIES CORP. |
TOTAL BILIRUBIN REAGENT |
06/24/1997 |
K891240 |
CATACHEM, INC. |
DIRECT BILIRUBIN FOR CONTINUOUS FLOW |
05/10/1989 |
K892905 |
CATACHEM, INC. |
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. |
06/19/1989 |
K891025 |
CATACHEM, INC. |
TOTAL BILIRUBIN FOR CONTINUOUS FLOW |
04/04/1989 |
K892668 |
CATACHEM, INC. |
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS |
07/20/1989 |
K861998 |
CIBA CORNING DIAGNOSTICS CORP. |
TOTAL BILIRUBIN TEST KIT |
06/27/1986 |
K854180 |
CLINICAL DATA, INC. |
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN |
11/25/1985 |
K040631 |
CLINICAL DATA, INC. |
VITALAB DIRECT BILIRUBIN REAGENT |
03/18/2004 |
K792465 |
CONNECTICUT DIAGNOSTICS, LTD. |
CONNECTICUT DIAGNOSTICS, LTS. DIRECT |
12/18/1979 |
K792338 |
CONNECTICUT DIAGNOSTICS, LTD. |
DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS |
12/06/1979 |
K902199 |
COULTER CORP. |
COULTER DIRECT BILIRUBIN |
06/12/1990 |
K901266 |
COULTER CORP. |
COULTER TOTAL BILIRUBIN REAGENT |
04/25/1990 |
K905622 |
COULTER ELECTRONICS, INC. |
COULTER DIRECT BILLRUBIN REAGENT |
12/26/1990 |
K981276 |
CRESTAT DIAGNOSTICS, INC. |
N-ASSAY L D-BIL |
05/01/1998 |
K981289 |
CRESTAT DIAGNOSTICS, INC. |
N-ASSAY L T-BIL |
04/27/1998 |
K060628 |
DADE BEHRING, INC. |
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR |
04/06/2006 |
K061839 |
DADE BEHRING, INC. |
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 |
08/29/2006 |
K061719 |
DADE BEHRING, INC. |
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 |
08/25/2006 |
K850901 |
DATA MEDICAL ASSOCIATES, INC. |
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE |
04/01/1985 |
K881166 |
DATA MEDICAL ASSOCIATES, INC. |
DIRECT BILIRUBIN PROCEDURE |
04/28/1988 |
K861671 |
DATA MEDICAL ASSOCIATES, INC. |
DIRECT BILIRUBIN PROCEDURE |
06/25/1986 |
K863265 |
DATA MEDICAL ASSOCIATES, INC. |
DIRECT BILIRUBIN PROCEDURE |
10/24/1986 |
K880397 |
DATA MEDICAL ASSOCIATES, INC. |
DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. |
03/15/1988 |
K861651 |
DATA MEDICAL ASSOCIATES, INC. |
TOTAL BILIRUBIN PROCEDURE |
05/29/1986 |
K955300 |
DATA MEDICAL ASSOCIATES, INC. |
TOTAL BILIRUBIN PROCEDURE |
12/20/1995 |
K863262 |
DATA MEDICAL ASSOCIATES, INC. |
TOTAL BILIRUBIN PROCEDURE |
09/17/1986 |
K880396 |
DATA MEDICAL ASSOCIATES, INC. |
TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. |
03/15/1988 |
K880395 |
DATA MEDICAL ASSOCIATES, INC. |
TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU. |
03/15/1988 |
K955940 |
DERMA MEDIA LAB., INC. |
TOTAL BILIRUBIN REAGENT |
03/13/1996 |
K981609 |
DIAGNOSTIC CHEMICALS LTD. |
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 |
06/03/1998 |
K023330 |
DIAGNOSTIC CHEMICALS LTD. |
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 |
12/11/2002 |
K955880 |
DIAGNOSTIC CHEMICALS LTD. |
DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 |
08/27/1996 |
K861094 |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02 |
04/21/1986 |
K861095 |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04 |
04/21/1986 |
K843032 |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
BILIRUBIN ASSAY KIT - TOTAL |
09/04/1984 |
K843027 |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
BILIRUBIN ASSAY KIT DIRECT |
09/04/1984 |
K974874 |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
BILIRUBIN-SL (TOTAL) ASSAY |
02/12/1998 |
K800686 |
DIAGNOSTIC SOLUTIONS, INC. |
REAGENT FOR DETERM. DIRECT BILIRUBIN |
05/28/1980 |
K800675 |
DIAGNOSTIC SOLUTIONS, INC. |
REAGENTS FOR DETERM. TOTAL BILIRUBIN |
05/28/1980 |
K842385 |
E.I. DUPONT DE NEMOURS & CO., INC. |
ACA CONJUGATED BILIRUBIN ANALYTICAL |
08/17/1984 |
K832357 |
E.I. DUPONT DE NEMOURS & CO., INC. |
ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK |
09/01/1983 |
K862359 |
E.I. DUPONT DE NEMOURS & CO., INC. |
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM |
08/19/1986 |
K840880 |
EASTMAN KODAK COMPANY |
EKTACHEM CLINICAL CHEM. SLIDES |
04/18/1984 |
K840606 |
EASTMAN KODAK COMPANY |
EKTACHEM CLINICAL CHEM. SLIDES |
04/04/1984 |
K921844 |
EASTMAN KODAK COMPANY |
KODAK EKTACHEM DT SLIDES (NBIL) |
07/21/1992 |
K030003 |
ELAN DIAGNOSTICS |
ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR |
09/29/2003 |
K030014 |
ELAN DIAGNOSTICS |
ATAC TOTAL BILIRUBIN REAGENT |
09/26/2003 |
K110780 |
ELITECH GROUP |
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II |
10/07/2011 |
K171401 |
ELITechGroup |
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 |
07/11/2017 |
K913466 |
EM DIAGNOSTIC SYSTEMS, INC. |
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20 |
10/25/1991 |
K913307 |
EM DIAGNOSTIC SYSTEMS, INC. |
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21 |
10/11/1991 |
K873551 |
EM DIAGNOSTIC SYSTEMS, INC. |
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95 |
10/02/1987 |
K885285 |
EM DIAGNOSTIC SYSTEMS, INC. |
DIRECT BILIRUBIN TEST CATALOG NO. SR1008 |
01/30/1989 |
K873424 |
EM DIAGNOSTIC SYSTEMS, INC. |
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 |
09/14/1987 |
K872513 |
EM DIAGNOSTIC SYSTEMS, INC. |
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 |
08/21/1987 |
K872512 |
EM DIAGNOSTIC SYSTEMS, INC. |
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 |
08/21/1987 |
K855079 |
EM DIAGNOSTIC SYSTEMS, INC. |
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 |
03/05/1986 |
K897175 |
EM DIAGNOSTIC SYSTEMS, INC. |
OLYMPUS DIRECT BILIRUBIN |
03/15/1990 |
K897174 |
EM DIAGNOSTIC SYSTEMS, INC. |
OLYMPUS(TM) TOTAL BILIRUBIN |
05/10/1990 |
K843329 |
EM DIAGNOSTIC SYSTEMS, INC. |
SYSTEMATE D-BILI 67213 |
09/20/1984 |
K932159 |
EM DIAGNOSTIC SYSTEMS, INC. |
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 |
09/21/1993 |
K895119 |
EM DIAGNOSTIC SYSTEMS, INC. |
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 |
10/17/1989 |
K922856 |
EM DIAGNOSTIC SYSTEMS, INC. |
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 |
09/09/1992 |
K843328 |
EM DIAGNOSTIC SYSTEMS, INC. |
SYSTEMATE T-BILI 67212 |
09/20/1984 |
K895118 |
EM DIAGNOSTIC SYSTEMS, INC. |
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407 |
10/17/1989 |
K902123 |
EM DIAGNOSTIC SYSTEMS, INC. |
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 |
06/06/1990 |
K897176 |
EM DIAGNOSTIC SYSTEMS, INC. |
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX |
03/19/1990 |
K931888 |
EM DIAGNOSTIC SYSTEMS, INC. |
TOTAL BILIRUBIN |
07/27/1993 |
K923083 |
EM DIAGNOSTIC SYSTEMS, INC. |
TOTAL BILIRUBIN CATALOG NO. 65407 |
09/09/1992 |
K885284 |
EM DIAGNOSTIC SYSTEMS, INC. |
TOTAL BILIRUBIN TEST CATALOG NO. SR1007 |
01/30/1989 |
K821462 |
EMD CHEMICALS INC. |
ULTRACHEM T-BILI, #64971 |
06/01/1982 |
K781610 |
FISHER SCIENTIFIC CO., LLC. |
BILIRUBIN DETERMINTAITON IN SERUM |
10/24/1978 |
K840111 |
FISHER SCIENTIFIC CO., LLC. |
TOTAL BILIRUBIN |
03/19/1984 |
K790578 |
GAMMA ENTERPRISES, INC. |
GAMMA SMAC REAGENTS |
05/15/1979 |
K771840 |
GAMMA ENTERPRISES, INC. |
TOTAL BILIRUBIN |
10/19/1977 |
K082210 |
GENZYME DIAGNOSTICS P.E.I. INC. |
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 |
12/16/2008 |
K831844 |
GILFORD DIAGNOSTICS |
DIRECT BILIRUBIN REAGENT |
07/18/1983 |
K831843 |
GILFORD DIAGNOSTICS |
GILCHEM TOTAL BILIRUBIN REAGENT |
07/18/1983 |
K761218 |
HARLECO |
AUTO TOTAL BILIRUBIN REAGENT |
12/21/1976 |
K761027 |
HARLECO |
AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN |
11/30/1976 |
K770121 |
HARLECO |
MANUEL BILIRUBIN REAGENT SET |
01/31/1977 |
K780524 |
HARLECO |
ULTRACHEM T-BILI 64971 GILFORD 3500 |
05/19/1978 |
K771092 |
HARLECO |
UNIPAK TOTAL & DIRECT BILIRUBIN |
07/21/1977 |
K771089 |
HARLECO |
UNIPAK TOTAL BILIRUBIN |
07/21/1977 |
K821873 |
HARLECO DIAGNOSTICS |
ULTRACHEM T-BILI |
07/14/1982 |
K892801 |
HERAEUS KULZER, INC. |
CLINISTAT TOTAL BILIRUBIN REAGENT TEST |
08/15/1989 |
K841572 |
HI CHEM, INC. |
DIRECT BILIRUBIN REAGENT |
05/16/1984 |
K830714 |
HI CHEM, INC. |
TOTAL BILIRUBIN REAGENT |
04/06/1983 |
K131217 |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN |
06/07/2013 |
K060325 |
HORIBA ABX |
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P |
08/16/2006 |
K930679 |
HORIZON DIAGNOSTICS, INC. |
DIRECT BILIRUBIN |
06/29/1993 |
K770458 |
ICN PHARMACEUTICALS, INC. |
BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. |
05/10/1977 |
K093623 |
INSTRUMENTATION LABORATORY CO. |
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO |
06/18/2010 |
K920653 |
INSTRUMENTATION LABORATORY CO. |
IL TEST BILIRUBIN TOTAL/DIRECT |
07/23/1992 |
K771621 |
INSTRUMENTATION LABORATORY CO. |
MULTISTAT III, TOTAL BILIRUBIN TEST |
09/13/1977 |
K011972 |
INTERSECT SYSTEMS, INC. |
DIRECT BILIRUBIN REAGENT |
08/27/2001 |
K003892 |
INTERSECT SYSTEMS, INC. |
TOTAL BILIRUBIN REAGENT |
02/20/2001 |
K863055 |
J. D. ASSOC. |
BILIFAST |
09/09/1986 |
K863056 |
J. D. ASSOC. |
BILIRUBIN TOTAL |
11/24/1986 |
K863057 |
J. D. ASSOC. |
BILIRUBIN TOTAL DIRECT |
09/26/1986 |
K760406 |
J.T. BAKER CHEMICAL CO. |
CAFFEINE DILUENT |
10/29/1976 |
K760408 |
J.T. BAKER CHEMICAL CO. |
POTASSIUM SODIUM TARTRATE |
11/02/1976 |
K760409 |
J.T. BAKER CHEMICAL CO. |
SODIUM NITRITE |
11/02/1976 |
K760407 |
J.T. BAKER CHEMICAL CO. |
SULFANILIC ACID |
10/29/1976 |
K003693 |
JAS Diagnostics, Inc. |
DIRECT BILIRUBIN |
01/29/2001 |
K003829 |
JAS Diagnostics, Inc. |
TOTAL BILIRUBIN |
02/12/2001 |
K811881 |
KING DIAGNOSTICS, INC. |
KING DIAGNOSTICS TOTAL BILIRUBIN TEST |
07/23/1981 |
K871115 |
LABO SCIENCE-USA, INC. |
UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. |
01/27/1989 |
K840757 |
LOGOS SCIENTIFIC, INC. |
ELVI 444 BILITRON |
05/30/1984 |
K091991 |
MEDICA CORP. |
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 |
09/04/2009 |
K080810 |
MEDICA CORP. |
EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT |
12/10/2008 |
K123802 |
MEDICA CORP. |
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT |
03/01/2013 |
K861413 |
MEDICAL ANALYSIS SYSTEMS, INC. |
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET |
04/24/1986 |
K893730 |
MEDICAL ANALYSIS SYSTEMS, INC. |
DIRECT BILIRUBIN REAGENT |
08/11/1989 |
K900259 |
MEDICAL ANALYSIS SYSTEMS, INC. |
DIRECT BILIRUBIN REAGENT |
02/27/1990 |
K841050 |
MEDICAL SPECIALTIES, INC. |
TOTAL BILIRUBIN REAGENT SET |
05/01/1984 |
K061830 |
NOVA BIOMEDICAL CORP. |
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ |
11/01/2006 |
K923608 |
OLYMPUS CORP. |
OLYMPUS DIRECT BILIRUBIN REAGENT |
08/18/1992 |
K924963 |
OLYMPUS CORP. |
OLYMPUS DIRECT BILIRUBIN REAGENT |
11/30/1992 |
K923609 |
OLYMPUS CORP. |
OLYMPUS TOTAL BILIRUBIN REAGENT |
10/02/1992 |
K924964 |
OLYMPUS CORP. |
OLYMPUS TOTAL BILIRUBIN REAGENT |
12/03/1992 |
K080435 |
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 |
09/05/2008 |
K821197 |
OMEGA MEDICAL ELECTRONICS |
TOTAL BILIRUBIN REAGENT SET |
07/13/1982 |
K190807 |
Ortho-Clinical Diagnostics, Inc. |
VITROS XT Chemistry Products TBIL-ALKP Slides |
04/26/2019 |
K802154 |
PANMED, INC. |
REAGENTS USED-QUAN. MEASURE OF SERUM |
10/10/1980 |
K780826 |
PIERCE CHEMICAL CO. |
BILIRUBIN RAPID STAT KIT |
05/26/1978 |
K914873 |
POINTE SCIENTIFIC, INC. |
DIAZO COLORIMETRY, BILIRUBIN |
12/04/1991 |
K832870 |
POINTE SCIENTIFIC, INC. |
DIAZO COLORIMETRY, BILLIRUBIN |
09/26/1983 |
K860257 |
POINTE SCIENTIFIC, INC. |
DIRECT BILIRUBIN |
02/21/1986 |
K040391 |
POINTE SCIENTIFIC, INC. |
TOTAL BILIRUBIN REAGENT SET |
06/02/2004 |
K111143 |
POLYMEDCO, INC. |
POLY-CHEM 90 TOTAL BILIRUBIN |
09/01/2011 |
K942949 |
PRISMA SYSTEMS |
BILIRUBIN (DIRECT) QVET |
11/22/1994 |
K942999 |
PRISMA SYSTEMS |
BILIRUBIN(TOTAL) QVET |
12/02/1994 |
K050869 |
RADIOMETER MEDICAL APS |
MODIFICATION TO ABL800 FLEX |
08/11/2005 |
K841892 |
REAGENTS APPLICATIONS, INC. |
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT |
06/07/1984 |
K063744 |
ROCHDIAG |
COBAS INTEGRA C 111 |
01/17/2007 |
K801117 |
ROCHE ANALYTICAL INSTRUMENTS, INC. |
COBAS TOTAL BILIRUBIN REAGENT & DILUENT |
06/09/1980 |
K896232 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
COBAS READY TOTAL BILIRUBIN REAGENT |
02/27/1990 |
K910593 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ROCHE REAGENT FOR DIRECT BILIRUBIN |
04/24/1991 |
K910591 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ROCHE REAGENT FOR TOTAL BILIRUBIN |
04/24/1991 |
K131544 |
Roche Diagnostics |
COBAS C BILIRUBIN TOTAL GEN.3 |
07/17/2013 |
K081193 |
Roche Diagnostics |
COBAS INTEGRA 400/800 BILIRUBIN TOTAL |
01/16/2009 |
K123965 |
Roche Diagnostics |
COBAS INTEGRA BILIRUBIN DIRECT GEN.2 |
02/28/2013 |
K063543 |
ROCHE DIAGNOSTICS CORP. |
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 |
12/22/2006 |
K981632 |
ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT |
06/15/1998 |
K832942 |
SANDARE CHEMICAL CO., INC. |
TOTAL & DIRECT BILIRUBIN PROCEDURES |
11/07/1983 |
K895822 |
SCLAVO, INC. |
TOTAL BILIRUBIN L.F. |
11/14/1989 |
K843178 |
SCLAVO, INC. |
TOTAL BILIRUBIN TEST |
09/07/1984 |
K832236 |
SIGMA CHEMICAL CO. |
SIGMA PROCEDURE #550 DETERM. BILIRUB |
08/31/1983 |
K872197 |
SIGMA DIAGNOSTICS, INC. |
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT |
08/13/1987 |
K760479 |
SIMMLER & SON, INC. |
REAGENT, TOTAL BILIRUBIN DETERMINATION |
10/29/1976 |
K874311 |
SIMMLER, INC. |
MULTICHEM (R) TOTAL BILIRUBIN |
11/25/1987 |
K840486 |
SOMAS MEDICAL INDUSTRIES, INC. |
TOTAL BILIRUBIN REAGENT |
04/25/1984 |
K810055 |
STANBIO LABORATORY |
STANBIO BILIRUBIN TEST SET |
02/02/1981 |
K860214 |
STERLING DIAGNOSTICS, INC. |
TOTAL BILIRUBIN REAGENT SET |
03/17/1986 |
K983304 |
SYNERMED INTL., INC. |
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT |
11/04/1998 |
K963939 |
SYNERMED, INC. |
SYNERMED DIRECT BILIRUBIN REAGENT KIT |
12/18/1996 |
K933026 |
SYNERMED, INC. |
SYNERMED DIRECT BILIRUBIN REAGENT KIT |
10/28/1993 |
K903728 |
SYNERMED, INC. |
SYNERMED DIRECT BILIRUBIN REAGENT KIT |
09/21/1990 |
K973109 |
SYNERMED, INC. |
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT |
09/25/1997 |
K972716 |
SYNERMED, INC. |
SYNERMED TOTAL BILIRUBIN REAGENT KIT |
08/07/1997 |
K940570 |
SYNERMED, INC. |
SYNERMED TOTAL BILIRUBIN REAGENT KIT |
04/20/1994 |
K902328 |
SYNERMED, INC. |
SYNERMED TOTAL BILIRUBIN REAGENT KIT |
06/28/1990 |
K881172 |
TECH-CO, INC. |
BILIRUBIN (DIRECT) |
06/07/1988 |
K875069 |
TECH-CO, INC. |
BILIRUBIN (TOTAL) |
01/11/1988 |
K882459 |
TECH-NEAL SCIENTIFIC, INC. |
DIAZO, COLORIMETRIC BILIRUBIN |
08/02/1988 |
K881241 |
TECH-NEAL SCIENTIFIC, INC. |
TOTAL BILIRUBIN REAGENT |
05/27/1988 |
K881798 |
TECHNICON INSTRUMENTS CORP. |
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN |
06/07/1988 |
K842809 |
TECHNICON INSTRUMENTS CORP. |
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN |
08/17/1984 |
K855195 |
TECHNOSTICS INTL. |
DIRECT & TOTAL BILIRUBIN SET |
01/14/1986 |
K820675 |
THE DOW CHEMICAL CO. |
BILIRUBIN(TOTAL) DETERMINATION CTMS |
04/01/1982 |
K820714 |
THE DOW CHEMICAL CO. |
DOW BILIRUBIN(DIRECT) DETERMINATION |
04/01/1982 |
K870365 |
TRACE SCIENTIFIC LTD. |
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD |
08/19/1987 |
K870364 |
TRACE SCIENTIFIC LTD. |
TOTAL BILIRUBIN REAGENT - DMSO METHOD |
08/19/1987 |
K890070 |
TRACE SCIENTIFIC LTD. |
TOTAL BILIRUBIN REAGENT, CONCENTRATED |
03/06/1989 |
K911866 |
TRACE SCIENTIFIC LTD. |
TRACE TOTAL/DIRECT BILIRUBIN REAGENT |
07/17/1991 |
K792411 |
VOLU SOL MEDICAL INDUSTRIES |
ELVI TOTAL BILIRUBIN & FRACTIONS |
12/06/1979 |
K792415 |
VOLU SOL MEDICAL INDUSTRIES |
ELVI TOTAL BILIRUBIN & FRACTIONS |
12/07/1979 |
K870095 |
WAKO CHEMICALS, USA, INC. |
BILIRUBIN TESTER |
06/03/1987 |
K970986 |
WAKO CHEMICALS, USA, INC. |
WAKO DIRECT BILIRUBIN V |
05/07/1997 |
K022962 |
WIENER LABORATORIES S.A.I.C. |
WIENER LAB. BILIRRUBINA TOTAL AA |
11/01/2002 |
K024116 |
WIENER LABORATORIES S.A.I.C. |
WIENER LAB. BILIRUBINA DIRECT AA |
02/12/2003 |
K832748 |
WORTHINGTON DIAGNOSTIC SYSTEMS |
COMPUR* EASYTOUCH TOTAL BILIRUBIN |
10/14/1983 |