Clearance Summary
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY received FDA 510(k) clearance under submission number K981913, sponsored by Chembio Diagnostic Systems, 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 1999-02-12.
- Submission: K981913
- Applicant / Sponsor: Chembio Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 1999-02-12
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.