Name: Predicase
Price: 199 USD

K-number	K221198
Device name	Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
Applicant	Thermo Fisher Scientific
Product code	NGZ
Device class	Class II
Decision date	Mar 10, 2023
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

Everything you need for a 510(k) submission. Nothing you don't.