The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas C 111 Analyzer.
| Device ID | K071211 |
| 510k Number | K071211 |
| Device Name: | COBAS C 111 ANALYZER |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Corina Harper |
| Correspondent | Corina Harper Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | CIT |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | DCN |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-01 |
| Decision Date | 2007-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630036820 | K071211 | 000 |
| 04015630036813 | K071211 | 000 |
| 04015630926916 | K071211 | 000 |
| 04015630922338 | K071211 | 000 |
| 04015630921942 | K071211 | 000 |