Documento fuente o registro público
FDA 510(k) K221899 — The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
FDA 510(k) index record K221899. Device: The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml. Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-01-20.
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"device_name": "The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml"
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2026-10-20
2026-10-30
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FDA 510(k) public index record K221899.
Device name: The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml. Applicant as listed: Thermo Fisher Scientific.
Decision date: 2023-01-20. Decision wording: Substantially Equivalent.
Product code: NGZ. Regulation: 21 CFR 866.1640. 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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