K063543 is an FDA 510(k) clearance for the COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226. This device is classified as a Diazo Colorimetry, Bilirubin (Class II - Special Controls, product code CIG).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 22, 2006, 28 days after receiving the submission on November 24, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K063543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2006 |
| Decision Date | December 22, 2006 |
| Days to Decision | 28 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 |