Source document or public record
FDA 510(k) K233367 — iDart Lyme IgG ImmunoBlot Kit
FDA 510(k) index record K233367. Device: iDart Lyme IgG ImmunoBlot Kit. Applicant as listed: Id-Fish Technology, Inc.. Decision date: 2024-08-12.
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"device_name": "iDart Lyme IgG ImmunoBlot Kit"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K233367.
Device name: iDart Lyme IgG ImmunoBlot Kit. Applicant as listed: Id-Fish Technology, Inc..
Decision date: 2024-08-12. Decision wording: Substantially Equivalent.
Product code: LSR. Regulation: 21 CFR 866.3830. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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