Clearance Summary
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit received FDA 510(k) clearance under submission number K203295, sponsored by Gold Standard Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2021-03-22.
- Submission: K203295
- Applicant / Sponsor: Gold Standard Diagnostics
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 2021-03-22
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.