cobas CMV
FDA 510(k) clearance K252481 · decided 2025-11-03
Clearance details
- K-number
- K252481
- Device name
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-07
- Decision date
- 2025-11-03
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- PAB
- Device class
- 2
- Regulation number
- 866.3180
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Alinity m CMV (K243485) | Abbott Molecular, Inc. | 2025-07-01 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
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 |