Documento fuente o registro público
FDA 510(k) K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
FDA 510(k) index record K242659. Device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-05-22.
Fuente
"device_name": "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL"
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2026-10-20
2026-10-25
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FDA 510(k) public index record K242659.
Device name: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL. Applicant as listed: Thermo Fisher Scientific.
Decision date: 2025-05-22. Decision wording: Substantially Equivalent.
Product code: JWY. 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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