Clearance Summary
MONOLISA ANTI-HAV EIA received FDA 510(k) clearance under submission number K063318, sponsored by Bio-Rad Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2007-05-03.
- Submission: K063318
- Applicant / Sponsor: Bio-Rad Laboratories
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3310
- Decision date: 2007-05-03
Classification & Regulation
This clearance is catalogued under FDA product code LOL and 21 CFR 866.3310, within the Microbiology review panel as a Class II device.