Roche Molecular Systems, Inc. · Class II · Cleared Sep 2, 2020
| K-number | K202215 |
| Device name | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | QMI |
| Device class | Class II |
| Decision date | Sep 2, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 866.3183 |
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