Clearance Summary
CLEARVIEW EXACT II INFLUENZA A & B TEST received FDA 510(k) clearance under submission number K103610, sponsored by Alere Scarborough, Inc D/B/A Binax, 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 2011-01-06.
- Submission: K103610
- Applicant / Sponsor: Alere Scarborough, Inc D/B/A Binax, Inc.
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3328
- Decision date: 2011-01-06
Classification & Regulation
This clearance is catalogued under FDA product code PSZ and 21 CFR 866.3328, within the Microbiology review panel as a Class II device.