CIG — Diazo Colorimetry, Bilirubin Class II
FDA product code CIG covers "Diazo Colorimetry, Bilirubin", a Class II medical device regulated under 21 CFR 862.1110. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CIG
- Device Class
- Class II
- Regulation Number
- 862.1110
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251998 | siemens healthcare diagnostics | Atellica CH Diazo Total Bilirubin (D_TBil) | February 27, 2026 |
| K223078 | siemens healthcare diagnostics | Atellica® CH Diazo Direct Bilirubin (D_DBil) | June 12, 2023 |
| K222104 | siemens healthcare diagnostics | Atellica® CH Diazo Total Bilirubin (D_TBil) | March 20, 2023 |
| K223324 | abbott ireland diagnostics division | Total Bilirubin2 | December 29, 2022 |
| K190807 | ortho-clinical diagnostics | VITROS XT Chemistry Products TBIL-ALKP Slides | April 26, 2019 |
| K171401 | elitechgroup | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN | July 11, 2017 |
| K150510 | abbott laboratories | Total Bilirubin | April 2, 2015 |
| K131544 | roche diagnostics | COBAS C BILIRUBIN TOTAL GEN.3 | July 17, 2013 |
| K131217 | hitachi chemical diagnostics | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | June 7, 2013 |
| K123802 | medica | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT | March 1, 2013 |
| K123965 | roche diagnostics | COBAS INTEGRA BILIRUBIN DIRECT GEN.2 | February 28, 2013 |
| K121985 | abbott laboratories | ARCHITECT TOTAL BILIRUBIN | February 1, 2013 |
| K110780 | elitechgroup | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, | October 7, 2011 |
| K111143 | polymedco | POLY-CHEM 90 TOTAL BILIRUBIN | September 1, 2011 |
| K093623 | instrumentation laboratory | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (AD | June 18, 2010 |
| K091991 | medica | EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 | September 4, 2009 |
| K081193 | roche diagnostics | COBAS INTEGRA 400/800 BILIRUBIN TOTAL | January 16, 2009 |
| K082210 | genzyme diagnostics p.e.i | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 | December 16, 2008 |
| K080810 | medica | EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON | December 10, 2008 |
| K080435 | olympus life science research europa gmbh (europa) | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 | September 5, 2008 |