cobas CTNG for use on cobas 6800/8800 systems
FDA 510(k) clearance K202408 · decided 2021-01-21
Clearance details
- K-number
- K202408
- Device name
- cobas CTNG for use on cobas 6800/8800 systems
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-21
- Decision date
- 2021-01-21
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- QEP
- Device class
- 2
- Regulation number
- 866.3393
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Roche Molecular Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |