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FDA 510(k) K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
FDA 510(k) index record K203292. Device: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit. Applicant as listed: Gold Standard Diagnostics. Decision date: 2021-03-22.
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"device_name": "Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit"
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K203292.
Device name: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit. Applicant as listed: Gold Standard Diagnostics.
Decision date: 2021-03-22. 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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