Panels › Clinical Chemistry › Product code CIG · Class 2
Diazo Colorimetry, Bilirubin
Regulation 862.1110
1510(k)s in 12 months (235 all time)
0recalls in 12 months (19 all time)
19recalls that name a 510(k)
Top companies in CIG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2026 | K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) Siemens Healthcare Diagnostics, Inc. | CIG |
| Jun 12, 2023 | K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) Siemens Healthcare Diagnostics, Inc. | CIG |
| Mar 20, 2023 | K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) Siemens Healthcare Diagnostics, Inc. | CIG |
| Dec 29, 2022 | K223324 | Total Bilirubin2 Abbott Ireland Diagnostics Division, IE | CIG |
| Apr 26, 2019 | K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides Ortho-Clinical Diagnostics, Inc. | CIG |
| Jul 11, 2017 | K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 Elitechgroup, FR | CIG |
| Apr 2, 2015 | K150510 | Total Bilirubin Abbott Laboratories | CIG |
| Jul 17, 2013 | K131544 | COBAS C BILIRUBIN TOTAL GEN.3 Roche Diagnostics | CIG |
| Jun 7, 2013 | K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN Hitachi Chemical Diagnostics, Inc. | CIG |
| Mar 1, 2013 | K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT Medica Corp. | CIG |
| Feb 28, 2013 | K123965 | COBAS INTEGRA BILIRUBIN DIRECT GEN.2 Roche Diagnostics | CIG |
| Feb 1, 2013 | K121985 | ARCHITECT TOTAL BILIRUBIN Abbott Laboratories | CIG |
| Oct 7, 2011 | K110780 | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II Elitechgroup | CIG |
| Sep 1, 2011 | K111143 | POLY-CHEM 90 TOTAL BILIRUBIN Polymedco, Inc. | CIG |
| Jun 18, 2010 | K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO Instrumentation Laboratory CO | CIG |
| Sep 4, 2009 | K091991 | EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 Medica Corp. | CIG |
| Jan 16, 2009 | K081193 | COBAS INTEGRA 400/800 BILIRUBIN TOTAL Roche Diagnostics | CIG |
| Dec 16, 2008 | K082210 | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 Genzyme Diagnostics P.E.I., Inc., CA | CIG |
| Dec 10, 2008 | K080810 | EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT Medica Corp. | CIG |
| Sep 5, 2008 | K080435 | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 Olympus Life Science Research Europa GmbH (Europa) | CIG |
| Jan 17, 2007 | K063744 | COBAS INTEGRA C 111 Rochdiag | CIG |
| Dec 22, 2006 | K063543 | COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 Roche Diagnostics Corp. | CIG |
| Nov 1, 2006 | K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ Nova Biomedical Corp. | CIG |
| Aug 29, 2006 | K061839 | DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 Dade Behring, Inc. | CIG |
| Aug 25, 2006 | K061719 | DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 Dade Behring, Inc. | CIG |
| Aug 16, 2006 | K060325 | ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P Horiba Abx, FR | CIG |
| May 3, 2006 | K060574 | TOTAL BILIRUBIN Abbott Laboratories | CIG |
| Apr 6, 2006 | K060628 | DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR Dade Behring, Inc. | CIG |
| Aug 11, 2005 | K050869 | MODIFICATION TO ABL800 FLEX Radiometer Medical Aps | CIG |
| Jun 17, 2005 | K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS Arkray, Inc. | CIG |
| Jun 2, 2004 | K040391 | TOTAL BILIRUBIN REAGENT SET Pointe Scientific, Inc., | CIG |
| Mar 18, 2004 | K040631 | VITALAB DIRECT BILIRUBIN REAGENT Clinical Data, Inc. | CIG |
| Sep 29, 2003 | K030003 | ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR Elan Diagnostics | CIG |
| Sep 26, 2003 | K030014 | ATAC TOTAL BILIRUBIN REAGENT Elan Diagnostics | CIG |
| Feb 12, 2003 | K024116 | WIENER LAB. BILIRUBINA DIRECT AA Wiener Laboratories Saic, AR | CIG |
| Dec 11, 2002 | K023330 | BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 Diagnostic Chemicals , Ltd., CA | CIG |
| Nov 1, 2002 | K022962 | WIENER LAB. BILIRRUBINA TOTAL AA Wiener Laboratories Saic, AR | CIG |
| Sep 13, 2002 | K022339 | TOTAL BILIRUBIN Abbott Laboratories | CIG |
| Sep 6, 2002 | K022180 | DIRECT BILIRUBIN Abbott Laboratories | CIG |
| Aug 27, 2001 | K011972 | DIRECT BILIRUBIN REAGENT Intersect Systems, Inc. | CIG |
| Feb 20, 2001 | K003892 | TOTAL BILIRUBIN REAGENT Intersect Systems, Inc. | CIG |
| Feb 12, 2001 | K003829 | TOTAL BILIRUBIN Jas Diagnostics, Inc. | CIG |
| Jan 29, 2001 | K003693 | DIRECT BILIRUBIN Jas Diagnostics, Inc. | CIG |
| Apr 10, 2000 | K993867 | BAYER ADVIA IMS SYSTEM Bayer Corp. | CIG |
| Dec 27, 1999 | K993771 | CARESIDE DIRECT BILIRUBIN Careside, Inc. | CIG |
| Aug 2, 1999 | K991866 | BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 A.P. Total Care, Inc. | CIG |
| May 28, 1999 | K991175 | MODIFICATION TO ALCYON DIRECT BILIRUBIN Abbott Laboratories | CIG |
| Nov 4, 1998 | K983304 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT Synermed Intl., Inc., CA | CIG |
| Sep 16, 1998 | K983133 | TBIL Abbott Laboratories | CIG |
| Sep 14, 1998 | K972382 | UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL Arrows Co., Ltd., JP | CIG |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.