Clearance Summary
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL received FDA 510(k) clearance under submission number K974809, sponsored by Boston Biomedica, 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 1998-02-05.
- Submission: K974809
- Applicant / Sponsor: Boston Biomedica, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 1998-02-05
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.