Clearance Summary
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System received FDA 510(k) clearance under submission number K223591, sponsored by Roche Molecular Systems, Inc.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2023-07-27.
- Submission: K223591
- Applicant / Sponsor: Roche Molecular Systems, Inc.
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3981
- Decision date: 2023-07-27
Classification & Regulation
This clearance is catalogued under FDA product code QOF and 21 CFR 866.3981, within the Microbiology review panel as a Class II device.