Documento fuente o registro público
FDA 510(k) K250789 — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
FDA 510(k) index record K250789. Device: Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50. Applicant as listed: Thermo Fisher Scientific (Oxoid Ltd.). Decision date: 2025-06-12.
Fuente
"device_name": "Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50"
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2026-10-20
2026-10-24
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FDA 510(k) public index record K250789.
Device name: Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50. Applicant as listed: Thermo Fisher Scientific (Oxoid Ltd.).
Decision date: 2025-06-12. 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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