510(k) K040560

ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING by Ab Biodisk — Product Code NGZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 27, 2004
Date Received: March 3, 2004
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 Biodisk

K081325 — ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML (July 24, 2008)
K052366 — ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCU (October 13, 2005)
K042392 — DAPTOMYCIN (December 13, 2004)
K042390 — ETEST FOR GEMIFLOXACIN (November 19, 2004)
K021445 — ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE (June 6, 2002)
K020748 — ETEST ERTAPENEM (April 29, 2002)
K010363 — ETEST MEROPENEM (April 9, 2001)
K002139 — ETEST LINEZOLID (November 8, 2000)
K001547 — ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP (August 7, 2000)
K000596 — ETEST GATIFLOXACIN (May 22, 2000)

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)