K123965 is an FDA 510(k) clearance for the COBAS INTEGRA BILIRUBIN DIRECT GEN.2. This device is classified as a Diazo Colorimetry, Bilirubin (Class II - Special Controls, product code CIG).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 28, 2013, 64 days after receiving the submission on December 26, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K123965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2012 |
| Decision Date | February 28, 2013 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |