cobas vivoDx MRSA
FDA 510(k) clearance DEN190016 · decided 2019-12-05
Clearance details
- K-number
- DEN190016
- Device name
- cobas vivoDx MRSA
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Unknown
- Date received
- 2019-03-19
- Decision date
- 2019-12-05
- Days to decision
- 261 days
- Clearance type
- Direct
- Product code
- QIV
- Device class
- 2
- Regulation number
- 866.1655
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| cobas® HPV (P190028/S022) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobsa® BRAF V600 Mutation Test (P110020/S043) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobas® KRAS Mutation Test (P140023/S031) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobas® HPV (P100020/S064) | Roche Molecular Systems, Inc. | 2025-12-31 |
| COBAS HPV TEST (P100020/S063) | Roche Molecular Systems, Inc. | 2025-12-15 |
| cobas® HBV (P150014/S056) | Roche Molecular Systems, Inc. | 2025-10-17 |
| cobas HPV (P190028/S021) | Roche Molecular Systems, Inc. | 2025-09-19 |
| cobas HBV (P150014/S058) | Roche Molecular Systems, Inc. | 2025-09-19 |