Name: Predicase
Price: 199 USD

K-number	K231433
Device name	The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
Applicant	Thermo Fisher Scientific
Product code	NGZ
Device class	Class II
Decision date	Aug 31, 2023
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL

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