Clearance Summary
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT received FDA 510(k) clearance under submission number K994004, sponsored by Inova Diagnostics, 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 2000-01-27.
- Submission: K994004
- Applicant / Sponsor: Inova Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 2000-01-27
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.