cobas liat SARS-CoV-2 v2 nucleic acid test— 510(k) K243346
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K243346 for cobas liat SARS-CoV-2 v2 nucleic acid test, Substantially Equivalent on 2025-04-11. Applicant: Roche Molecular Systems, Inc..
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code QWR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Pleasanton, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.