510(k) K233367
K233367 is an FDA 510(k) premarket notification submitted by Id-Fish Technology, Inc. for the device "iDart Lyme IgG ImmunoBlot Kit". The FDA issued a decision of Substantially Equivalent on August 12, 2024. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Id-Fish Technology, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2024
- Date Received
- October 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Borrelia Serological Reagent
- Device Class
- Class II
- Regulation Number
- 866.3830
- Review Panel
- MI
- Submission Type