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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