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510(k) K221198

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL by Thermo Fisher Scientific — Product Code NGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2023
Date Received
April 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Plate, Antifungal
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.

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Other clearances for product code NGZ

  • K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution ra (February 27, 2025)
  • K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (June 12, 2024)
  • K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (June 7, 2024)
  • K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution ra (August 31, 2023)
  • K221899 — The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution r (January 20, 2023)
  • K211539 — Sensititre YeastOne Susceptibility System with Voriconazole in the dilution rang (December 15, 2021)
  • K181368 — VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (June 20, 2018)
  • K151923 — VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (March 25, 2016)
  • K151817 — VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (February 18, 2016)
  • K133952 — VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE (August 19, 2014)