Clearance Summary
PLATELIA LYME IGM received FDA 510(k) clearance under submission number K081362, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2008-06-26.
- Submission: K081362
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 2008-06-26
Classification & Regulation
This clearance is catalogued under FDA product code LSR and 21 CFR 866.3830, within the Microbiology review panel as a Class II device.