510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243738Substantially Equivalent

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL

Thermo Fisher Scientific Oy, Oakwood Village OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K243738 is the FDA 510(k) clearance record for The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL, a class II device, cleared for Thermo Fisher Scientific on under FDA product code NGZ (Susceptibility Test Plate, Antifungal). FDA's definition for product code NGZ reads: "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". FDA records list 65 510(k) clearances for Thermo Fisher Scientific, from to . As of , FDA records show no recalls naming K243738.

Clearance record

Decision date
Received
(85 days to decision)
Product code
NGZ Susceptibility Test Plate, Antifungal
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Thermo Fisher Scientific 1 Thermofisher Way, Oakwood Village OH
510(k) summary
Statement
Third party review
No

Clearances, product code NGZ

Trailing 12 months

FDA records hold no clearances under product code NGZ in the trailing twelve months.

FDA records show no clearances under product code NGZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NGZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260