Sensititre YeastOne Susceptibility System With Voriconazole In The Dilution Range Of 0.008 - 8 Ug/mL

Susceptibility Test Plate, Antifungal

Thermo Fisher Scientific

The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Sensititre Yeastone Susceptibility System With Voriconazole In The Dilution Range Of 0.008 - 8 Ug/ml.

Pre-market Notification Details

Device IDK211539
510k NumberK211539
Device Name:Sensititre YeastOne Susceptibility System With Voriconazole In The Dilution Range Of 0.008 - 8 Ug/mL
ClassificationSusceptibility Test Plate, Antifungal
Applicant Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village,  OH  44146
ContactCynthia Knapp
CorrespondentCynthia Knapp
Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village,  OH  44146
Product CodeNGZ  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-18
Decision Date2021-12-15

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