Clearance Summary
Anti-Borrelia burgdorferi US Westernblot (IgG) received FDA 510(k) clearance under submission number K161513, sponsored by Euroimmun US. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2016-08-25.
- Submission: K161513
- Applicant / Sponsor: Euroimmun US
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 2016-08-25
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.