Clearance Summary
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY received FDA 510(k) clearance under submission number K020806, sponsored by Bayer Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2002-03-27.
- Submission: K020806
- Applicant / Sponsor: Bayer Corp.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2002-03-27
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.