Source document or public record
FDA 510(k) K193508 — Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
FDA 510(k) index record K193508. Device: Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20. Applicant as listed: Oxoid Limited (Part of Thermo Fisher Scientific). Decision date: 2020-12-04.
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"device_name": "Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20"
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 K193508.
Device name: Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20. Applicant as listed: Oxoid Limited (Part of Thermo Fisher Scientific).
Decision date: 2020-12-04. 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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