K242872
- 510(k) number
- K242872
- Device name
- iDart Lyme IgM ImmunoBlot Kit
- Applicant
- Id-Fish Technology, Inc. CA · US
- Product code
- LSR — Reagent, Borrelia Serological Reagent
- Decision date
- 2025-06-12
- Date received
- 2024-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242872.pdf
Official FDA record: K242872
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.