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 K153544, sponsored by Iquum, 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 2016-07-25.
- Submission: K153544
- Applicant / Sponsor: Iquum, Inc.
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3980
- Decision date: 2016-07-25
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.