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510(k) K082534

ETEST VORICONAZOLE 0.002-32 UG/ML by Ab Biomerieux — Product Code NGZ

K082534 is an FDA 510(k) premarket notification submitted by Ab Biomerieux for the device "ETEST VORICONAZOLE 0.002-32 UG/ML". The FDA issued a decision of Substantially Equivalent on November 2, 2009. The device falls under product code NGZ (Susceptibility Test Plate, Antifungal), a Class II device regulated under 21 CFR 866.1640. Ab Biomerieux has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2009
Date Received
September 2, 2008
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.

Other clearances by Ab Biomerieux

  • K093604 — ETEST MOXIFLOXACIN 0.002-32 UG/ML (August 25, 2010)

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)
  • K221198 — Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range (March 10, 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)

FDA data resources