Clearance Summary
ALERE I INFLUENZA A & B received FDA 510(k) clearance under submission number K141520, sponsored by Alere Scarborough, Inc D/B/A Binax, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2014-06-13.
- Submission: K141520
- Applicant / Sponsor: Alere Scarborough, Inc D/B/A Binax, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3980
- Decision date: 2014-06-13
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.