Clearance Summary
OLYMPUS AFP - ALPHA-FETOPROTEIN received FDA 510(k) clearance under submission number K081709, sponsored by Olympus Life Science Research Europa GmbH (Europa). The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2009-03-16.
- Submission: K081709
- Applicant / Sponsor: Olympus Life Science Research Europa GmbH (Europa)
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2009-03-16
Classification & Regulation
This clearance is catalogued under FDA product code LOJ and 21 CFR 866.6010, within the Immunology review panel as a Class II device.