The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas C Bilirubin Total Gen.3.
| Device ID | K131544 |
| 510k Number | K131544 |
| Device Name: | COBAS C BILIRUBIN TOTAL GEN.3 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | Roche Diagnostics 9115 SOUTH HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Lisa K Klinedinst |
| Correspondent | Lisa K Klinedinst Roche Diagnostics 9115 SOUTH HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2013-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121078 | K131544 | 000 |
| 04015630928910 | K131544 | 000 |
| 04015630928903 | K131544 | 000 |
| 04015630928897 | K131544 | 000 |