FDA Product Code
FDA Product Code CIG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1110
510(k) Clearances — 235 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 | Traditional | PDF ↗ |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | 2023-06-12 | Traditional | PDF ↗ |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2023-03-20 | Traditional | PDF ↗ |
| K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | 2022-12-29 | Traditional | PDF ↗ |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-26 | Traditional | PDF ↗ |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | Elitechgroup | 2017-07-11 | Traditional | PDF ↗ |
| K150510 | Total Bilirubin | Abbott Laboratories | 2015-04-02 | Traditional | PDF ↗ |
| K131544 | COBAS C BILIRUBIN TOTAL GEN.3 | Roche Diagnostics | 2013-07-17 | Traditional | PDF ↗ |
| K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 | Traditional | PDF ↗ |
| K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT | Medica Corp. | 2013-03-01 | Traditional | PDF ↗ |
| K123965 | COBAS INTEGRA BILIRUBIN DIRECT GEN.2 | Roche Diagnostics | 2013-02-28 | Traditional | PDF ↗ |
| K121985 | ARCHITECT TOTAL BILIRUBIN | Abbott Laboratories | 2013-02-01 | Traditional | PDF ↗ |
| K110780 | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II | Elitechgroup | 2011-10-07 | Traditional | PDF ↗ |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | Polymedco, Inc. | 2011-09-01 | Traditional | PDF ↗ |
| K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO | Instrumentation Laboratory CO | 2010-06-18 | Traditional | PDF ↗ |
| K091991 | EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 | Medica Corp. | 2009-09-04 | Special | PDF ↗ |
| K081193 | COBAS INTEGRA 400/800 BILIRUBIN TOTAL | Roche Diagnostics | 2009-01-16 | Special | PDF ↗ |
| K082210 | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 | Genzyme Diagnostics P.E.I., Inc. | 2008-12-16 | Traditional | PDF ↗ |
| K080810 | EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT | Medica Corp. | 2008-12-10 | Traditional | PDF ↗ |
| K080435 | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-05 | Traditional | PDF ↗ |
| K063744 | COBAS INTEGRA C 111 | Rochdiag | 2007-01-17 | Special | PDF ↗ |
| K063543 | COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 | Roche Diagnostics Corp. | 2006-12-22 | Special | PDF ↗ |
| K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ | Nova Biomedical Corp. | 2006-11-01 | Traditional | PDF ↗ |
| K061839 | DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 | Dade Behring, Inc. | 2006-08-29 | Traditional | PDF ↗ |
| K061719 | DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 | Dade Behring, Inc. | 2006-08-25 | Traditional | PDF ↗ |
| K060325 | ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P | Horiba Abx | 2006-08-16 | Traditional | PDF ↗ |
| K060574 | TOTAL BILIRUBIN | Abbott Laboratories | 2006-05-03 | Traditional | PDF ↗ |
| K060628 | DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR | Dade Behring, Inc. | 2006-04-06 | Special | PDF ↗ |
| K050869 | MODIFICATION TO ABL800 FLEX | Radiometer Medical Aps | 2005-08-11 | Special | PDF ↗ |
| K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | Arkray, Inc. | 2005-06-17 | Traditional | PDF ↗ |
| K040391 | TOTAL BILIRUBIN REAGENT SET | Pointe Scientific, Inc., | 2004-06-02 | Traditional | PDF ↗ |
| K040631 | VITALAB DIRECT BILIRUBIN REAGENT | Clinical Data, Inc. | 2004-03-18 | Traditional | PDF ↗ |
| K030003 | ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR | Elan Diagnostics | 2003-09-29 | Traditional | PDF ↗ |
| K030014 | ATAC TOTAL BILIRUBIN REAGENT | Elan Diagnostics | 2003-09-26 | Traditional | PDF ↗ |
| K024116 | WIENER LAB. BILIRUBINA DIRECT AA | Wiener Laboratories Saic | 2003-02-12 | Traditional | PDF ↗ |
| K023330 | BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 | Diagnostic Chemicals , Ltd. | 2002-12-11 | Traditional | PDF ↗ |
| K022962 | WIENER LAB. BILIRRUBINA TOTAL AA | Wiener Laboratories Saic | 2002-11-01 | Traditional | PDF ↗ |
| K022339 | TOTAL BILIRUBIN | Abbott Laboratories | 2002-09-13 | Traditional | PDF ↗ |
| K022180 | DIRECT BILIRUBIN | Abbott Laboratories | 2002-09-06 | Traditional | PDF ↗ |
| K011972 | DIRECT BILIRUBIN REAGENT | Intersect Systems, Inc. | 2001-08-27 | Traditional | PDF ↗ |
| K003892 | TOTAL BILIRUBIN REAGENT | Intersect Systems, Inc. | 2001-02-20 | Traditional | PDF ↗ |
| K003829 | TOTAL BILIRUBIN | Jas Diagnostics, Inc. | 2001-02-12 | Traditional | PDF ↗ |
| K003693 | DIRECT BILIRUBIN | Jas Diagnostics, Inc. | 2001-01-29 | Traditional | PDF ↗ |
| K993867 | BAYER ADVIA IMS SYSTEM | Bayer Corp. | 2000-04-10 | Traditional | PDF ↗ |
| K993771 | CARESIDE DIRECT BILIRUBIN | Careside, Inc. | 1999-12-27 | Traditional | PDF ↗ |
| K991866 | BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 | A.P. Total Care, Inc. | 1999-08-02 | Traditional | PDF ↗ |
| K991175 | MODIFICATION TO ALCYON DIRECT BILIRUBIN | Abbott Laboratories | 1999-05-28 | Traditional | PDF ↗ |
| K983304 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT | Synermed Intl., Inc. | 1998-11-04 | Traditional | PDF ↗ |
| K983133 | TBIL | Abbott Laboratories | 1998-09-16 | Traditional | PDF ↗ |
| K972382 | UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL | Arrows Co., Ltd. | 1998-09-14 | Traditional | PDF ↗ |
| K981943 | DBIL | Abbott Laboratories | 1998-07-22 | Traditional | PDF ↗ |
| K981883 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 | Boehringer Mannheim Corp. | 1998-07-07 | Traditional | PDF ↗ |
| K981588 | CARESIDE TOTAL BILIRUBIN | Careside, Inc. | 1998-06-23 | Traditional | PDF ↗ |
| K981632 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-06-15 | Traditional | PDF ↗ |
| K981609 | BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 | Diagnostic Chemicals , Ltd. | 1998-06-03 | Traditional | PDF ↗ |
| K981336 | TBIL | Abbott Laboratories | 1998-05-01 | Traditional | PDF ↗ |
| K981276 | N-ASSAY L D-BIL | Crestat Diagnostics, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K981289 | N-ASSAY L T-BIL | Crestat Diagnostics, Inc. | 1998-04-27 | Traditional | PDF ↗ |
| K981222 | DIRECT BILIRUBIN (DBIL) | Abbott Laboratories | 1998-04-24 | Traditional | PDF ↗ |
| K974874 | BILIRUBIN-SL (TOTAL) ASSAY | Diagnostic Chemicals, Ltd. (Usa) | 1998-02-12 | Traditional | PDF ↗ |
| K973109 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT | Synermed, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K972716 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | Synermed, Inc. | 1997-08-07 | Traditional | PDF ↗ |
| K972073 | TOTAL BILIRUBIN REAGENT | Carolina Liquid Chemistries Corp. | 1997-06-24 | Traditional | PDF ↗ |
| K970986 | WAKO DIRECT BILIRUBIN V | Wako Chemicals USA, Inc. | 1997-05-07 | Traditional | PDF ↗ |
| K963939 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | Synermed, Inc. | 1996-12-18 | Traditional | PDF ↗ |
| K955880 | DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 | Diagnostic Chemicals , Ltd. | 1996-08-27 | Traditional | PDF ↗ |
| K955940 | TOTAL BILIRUBIN REAGENT | Derma Media Lab., Inc. | 1996-03-13 | Traditional | PDF ↗ |
| K955300 | TOTAL BILIRUBIN PROCEDURE | Data Medical Associates, Inc. | 1995-12-20 | Traditional | PDF ↗ |
| K942999 | BILIRUBIN(TOTAL) QVET | Prisma Systems | 1994-12-02 | Traditional | PDF ↗ |
| K942949 | BILIRUBIN (DIRECT) QVET | Prisma Systems | 1994-11-22 | Traditional | PDF ↗ |
| K934068 | BECKMAN DIRECT BILIRUBIN REAGENT | Beckman-Diagnostic Systems Group | 1994-04-26 | Traditional | PDF ↗ |
| K940570 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | Synermed, Inc. | 1994-04-20 | Traditional | PDF ↗ |
| K933026 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | Synermed, Inc. | 1993-10-28 | Traditional | PDF ↗ |
| K932159 | SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 | Em Diagnostic Systems, Inc. | 1993-09-21 | Traditional | PDF ↗ |
| K931888 | TOTAL BILIRUBIN | Em Diagnostic Systems, Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K930679 | DIRECT BILIRUBIN | Horizon Diagnostics, Inc. | 1993-06-29 | Traditional | PDF ↗ |
| K924964 | OLYMPUS TOTAL BILIRUBIN REAGENT | Olympus Corp. | 1992-12-03 | Traditional | PDF ↗ |
| K924963 | OLYMPUS DIRECT BILIRUBIN REAGENT | Olympus Corp. | 1992-11-30 | Traditional | PDF ↗ |
| K923609 | OLYMPUS TOTAL BILIRUBIN REAGENT | Olympus Corp. | 1992-10-02 | Traditional | PDF ↗ |
| K922856 | SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K923083 | TOTAL BILIRUBIN CATALOG NO. 65407 | Em Diagnostic Systems, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K923608 | OLYMPUS DIRECT BILIRUBIN REAGENT | Olympus Corp. | 1992-08-18 | Traditional | PDF ↗ |
| K920653 | IL TEST BILIRUBIN TOTAL/DIRECT | Instrumentation Laboratory CO | 1992-07-23 | Traditional | PDF ↗ |
| K921844 | KODAK EKTACHEM DT SLIDES (NBIL) | Eastman Kodak Company | 1992-07-21 | Traditional | PDF ↗ |
| K914873 | DIAZO COLORIMETRY, BILIRUBIN | Pointe Scientific, Inc., | 1991-12-04 | Traditional | PDF ↗ |
| K913466 | ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20 | Em Diagnostic Systems, Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K913307 | ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21 | Em Diagnostic Systems, Inc. | 1991-10-11 | Traditional | PDF ↗ |
| K912733 | AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT | Amersham Corp. | 1991-07-22 | Traditional | PDF ↗ |
| K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT | Trace Scientific , Ltd. | 1991-07-17 | Traditional | PDF ↗ |
| K910635 | TOTAL BILIRUBIN REAGENT SET | Biochemical Trade, Inc. | 1991-05-15 | Traditional | PDF ↗ |
| K910591 | ROCHE REAGENT FOR TOTAL BILIRUBIN | Roche Diagnostic Systems, Inc. | 1991-04-24 | Traditional | PDF ↗ |
| K910593 | ROCHE REAGENT FOR DIRECT BILIRUBIN | Roche Diagnostic Systems, Inc. | 1991-04-24 | Traditional | PDF ↗ |
| K904468 | DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 | Amresco, Inc. | 1991-01-17 | Traditional | PDF ↗ |
| K905622 | COULTER DIRECT BILLRUBIN REAGENT | Coulter Electronics, Inc. | 1990-12-26 | Traditional | PDF ↗ |
| K904381 | DIAZO COLORIMENTRY DIRECT BILIRUBIN | Amresco, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K903728 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | Synermed, Inc. | 1990-09-21 | Traditional | PDF ↗ |
| K902801 | BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT | Beckman Instruments, Inc. | 1990-07-17 | Traditional | PDF ↗ |
| K902328 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | Synermed, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K902199 | COULTER DIRECT BILIRUBIN | Coulter Corp. | 1990-06-12 | Traditional | PDF ↗ |
| K902123 | SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 | Em Diagnostic Systems, Inc. | 1990-06-06 | Traditional | PDF ↗ |
Product code CIG · Class II · Clinical Chemistry. Data: openFDA.