Clearance Summary
PLATELIA LYME IGG ASSAY received FDA 510(k) clearance under submission number K080012, 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 2008-05-08.
- Submission: K080012
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 2008-05-08
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.