FDA 510(k) Applications for Medical Device Product Code "CIG"
(Diazo Colorimetry, Bilirubin)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991866 | A.P. TOTAL CARE, INC. | BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 | 08/02/1999 |
| K223324 | Abbott Ireland Diagnostics Division | Total Bilirubin2 | 12/29/2022 |
| 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 |
| 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 |
| 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 |
| K040631 | CLINICAL DATA, INC. | VITALAB DIRECT BILIRUBIN REAGENT | 03/18/2004 |
| 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 |
| 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 |
| K974874 | DIAGNOSTIC CHEMICALS, LTD. (USA) | BILIRUBIN-SL (TOTAL) ASSAY | 02/12/1998 |
| 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 |
| K082210 | GENZYME DIAGNOSTICS P.E.I. INC. | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 | 12/16/2008 |
| 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 |
| 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 |
| K011972 | INTERSECT SYSTEMS, INC. | DIRECT BILIRUBIN REAGENT | 08/27/2001 |
| K003892 | INTERSECT SYSTEMS, INC. | TOTAL BILIRUBIN REAGENT | 02/20/2001 |
| K003693 | JAS Diagnostics, Inc. | DIRECT BILIRUBIN | 01/29/2001 |
| K003829 | JAS Diagnostics, Inc. | TOTAL BILIRUBIN | 02/12/2001 |
| 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 |
| K061830 | NOVA BIOMEDICAL CORP. | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ | 11/01/2006 |
| K080435 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 | 09/05/2008 |
| K190807 | Ortho-Clinical Diagnostics, Inc. | VITROS XT Chemistry Products TBIL-ALKP Slides | 04/26/2019 |
| K040391 | POINTE SCIENTIFIC, INC. | TOTAL BILIRUBIN REAGENT SET | 06/02/2004 |
| K111143 | POLYMEDCO, INC. | POLY-CHEM 90 TOTAL BILIRUBIN | 09/01/2011 |
| K050869 | RADIOMETER MEDICAL APS | MODIFICATION TO ABL800 FLEX | 08/11/2005 |
| K063744 | ROCHDIAG | COBAS INTEGRA C 111 | 01/17/2007 |
| 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 |
| K223078 | Siemens Healthcare Diagnostics Inc. | Atellica« CH Diazo Direct Bilirubin (D_DBil) | 06/12/2023 |
| K222104 | Siemens Healthcare Diagnostics Inc. | Atellica« CH Diazo Total Bilirubin (D_TBil) | 03/20/2023 |
| 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 |
| K973109 | SYNERMED, INC. | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT | 09/25/1997 |
| K972716 | SYNERMED, INC. | SYNERMED TOTAL BILIRUBIN REAGENT KIT | 08/07/1997 |
| 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 |
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