cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
FDA 510(k) clearance K243406 · decided 2025-04-25
Clearance details
- K-number
- K243406
- Device name
- cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-01
- Decision date
- 2025-04-25
- Days to decision
- 175 days
- Clearance type
- Dual Track
- Product code
- QOF
- Device class
- 2
- Regulation number
- 866.3981
- 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
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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/S023) | Roche Molecular Systems, Inc. | 2026-06-16 |
| cobas® HPV (P190028/S024) | Roche Molecular Systems, Inc. | 2026-04-23 |
| cobas® HPV (P190028/S025) | Roche Molecular Systems, Inc. | 2026-03-17 |
| cobas® KRAS Mutation Test (P140023/S032) | Roche Molecular Systems, Inc. | 2026-03-17 |
| cobas® HPV (P100020/S065) | Roche Molecular Systems, Inc. | 2026-03-17 |
| cobas® BRAF V600 Mutation Test (P110020/S044) | Roche Molecular Systems, Inc. | 2026-03-17 |
| 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 |