Clearance Summary
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance under submission number K213822, sponsored by Roche Molecular Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2022-07-06.
- Submission: K213822
- Applicant / Sponsor: Roche Molecular Systems, Inc.
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3980
- Decision date: 2022-07-06
Classification & Regulation
This clearance is catalogued under FDA product code OCC and 21 CFR 866.3980, within the Microbiology review panel as a Class II device.