cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
FDA 510(k) clearance K223591 · decided 2023-07-27
Clearance details
- K-number
- K223591
- Device name
- cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-01
- Decision date
- 2023-07-27
- Days to decision
- 238 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
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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 |