Clearance Summary
MONOLISA ANTI-HAV IGM EIA received FDA 510(k) clearance under submission number K092353, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2009-10-29.
- Submission: K092353
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3310
- Decision date: 2009-10-29
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.