iDart Lyme IgM ImmunoBlot Kit— 510(k) K242872

Name: FDA 510(k) clearance K242872
Creator: U.S. Food and Drug Administration
Published: 2025-06-12

Substantially Equivalent

Id-Fish Technology, Inc.

FDA 510(k) clearance K242872 for iDart Lyme IgM ImmunoBlot Kit, Substantially Equivalent on 2025-06-12. Applicant: Id-Fish Technology, Inc.. Device class: 2.

Clearance details

Applicant: Id-Fish Technology, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2024-09-23
Decision date: 2025-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

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