cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System— 510(k) K223591
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K223591 for cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System, Substantially Equivalent on 2023-07-27. Applicant: Roche Molecular Systems, Inc..
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code QOF
- 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.