Class Class II

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198)

K221198 2023-03-10 Traditional
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Description

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL by Thermo Fisher Scientific — FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221198
Clearance Date2023-03-10
Clearance TypeTraditional
Product CodeNGZ
Regulation Number866.1640

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