Source document or public record
FDA 510(k) K221198 — Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
FDA 510(k) index record K221198. Device: Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-03-10.
Source
"device_name": "Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K221198.
Device name: Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL. Applicant as listed: Thermo Fisher Scientific.
Decision date: 2023-03-10. 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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.