Clearance Summary
BinaxNOW G6PD Test received FDA 510(k) clearance under submission number K161364, sponsored by Alere Scarborough, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2016-06-17.
- Submission: K161364
- Applicant / Sponsor: Alere Scarborough, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7360
- Decision date: 2016-06-17
Classification & Regulation
This clearance is catalogued under FDA product code JBF and 21 CFR 864.7360, within the Hematology review panel as a Class II device.