FDA 510(k) Applications for Medical Device Product Code "CIG"
(Diazo Colorimetry, Bilirubin)

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
K983133 ABBOTT LABORATORIES TBIL 09/16/1998
K981336 ABBOTT LABORATORIES TBIL 05/01/1998
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
K955300 DATA MEDICAL ASSOCIATES, INC. TOTAL BILIRUBIN PROCEDURE 12/20/1995
K861651 DATA MEDICAL ASSOCIATES, INC. TOTAL BILIRUBIN PROCEDURE 05/29/1986
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
K840606 EASTMAN KODAK COMPANY EKTACHEM CLINICAL CHEM. SLIDES 04/04/1984
K840880 EASTMAN KODAK COMPANY EKTACHEM CLINICAL CHEM. SLIDES 04/18/1984
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
K900259 MEDICAL ANALYSIS SYSTEMS, INC. DIRECT BILIRUBIN REAGENT 02/27/1990
K893730 MEDICAL ANALYSIS SYSTEMS, INC. DIRECT BILIRUBIN REAGENT 08/11/1989
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
K924964 OLYMPUS CORP. OLYMPUS TOTAL BILIRUBIN REAGENT 12/03/1992
K923609 OLYMPUS CORP. OLYMPUS TOTAL BILIRUBIN REAGENT 10/02/1992
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
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


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