Source document or public record
FDA 510(k) K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
FDA 510(k) index record K251337. Device: Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10. Applicant as listed: Thermo Fisher Scientific (Oxoid Ltd.). Decision date: 2025-12-05.
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"device_name": "Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10"
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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K251337.
Device name: Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10. Applicant as listed: Thermo Fisher Scientific (Oxoid Ltd.).
Decision date: 2025-12-05. Decision wording: Substantially Equivalent.
Product code: JTN. Regulation: 21 CFR 866.1620. 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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