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FDA 510(k) K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG)
FDA 510(k) index record K193115. Device: EUROIMMUN Anti-BP230-CF ELISA (IgG). Applicant as listed: Euroimmun Us, Inc.. Decision date: 2020-09-17.
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"device_name": "EUROIMMUN Anti-BP230-CF ELISA (IgG)"
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 K193115.
Device name: EUROIMMUN Anti-BP230-CF ELISA (IgG). Applicant as listed: Euroimmun Us, Inc..
Decision date: 2020-09-17. Decision wording: Substantially Equivalent.
Product code: OEG. Regulation: 21 CFR 866.5660. Medical specialty: Immunology.
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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