Clearance Summary
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 received FDA 510(k) clearance under submission number K083744, sponsored by Binax, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2009-09-01.
- Submission: K083744
- Applicant / Sponsor: Binax, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2009-09-01
Classification & Regulation
This clearance is catalogued under FDA product code MJZ and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.