Clearance Summary
IMMUNO DOT BORRELIA DOT BLOT G TEST received FDA 510(k) clearance under submission number K953682, sponsored by Genbio. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 1996-05-03.
- Submission: K953682
- Applicant / Sponsor: Genbio
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 1996-05-03
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.