Clearance Summary
iDart Lyme IgG ImmunoBlot Kit received FDA 510(k) clearance under submission number K233367, sponsored by Id-Fish Technology, 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 2024-08-12.
- Submission: K233367
- Applicant / Sponsor: Id-Fish Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3830
- Decision date: 2024-08-12
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.