K233367
- 510(k) number
- K233367
- Device name
- iDart Lyme IgG ImmunoBlot Kit
- Applicant
- Id-Fish Technology, Inc. CA · US
- Product code
- LSR — Reagent, Borrelia Serological Reagent
- Decision date
- 2024-08-12
- Date received
- 2023-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233367.pdf
Official FDA record: K233367
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.