Clearance Summary
FANA 60 received FDA 510(k) clearance under submission number K854314, sponsored by American Bio-Reagents, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1985-12-16.
- Submission: K854314
- Applicant / Sponsor: American Bio-Reagents, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1985-12-16
Classification & Regulation
This clearance is catalogued under FDA product code DHN and 21 CFR 866.5100, within the Immunology review panel as a Class II device.