Roche Molecular Systems, Inc. · Class II · Cleared May 22, 2019
| K-number | K190433 |
| Device name | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | QEP |
| Device class | Class II |
| Decision date | May 22, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 866.3393 |
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