K081193 is an FDA 510(k) clearance for the COBAS INTEGRA 400/800 BILIRUBIN TOTAL. 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 January 16, 2009, 263 days after receiving the submission on April 28, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K081193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2008 |
| Decision Date | January 16, 2009 |
| Days to Decision | 263 days |
| Submission Type | Special |
| 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 |