Roche Diagnostics · Class II · Cleared May 14, 2012
| K-number | K111188 |
| Device name | COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B |
| Applicant | Roche Diagnostics |
| Product code | CHL |
| Device class | Class II |
| Decision date | May 14, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.1120 |
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