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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Plate, Antifungal
510(k) Number K211539
Device Name Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
Applicant
Thermo Fisher Scientific
1 Thermo Fisher Way
Oakwood Village,  OH  44146
Applicant Contact Cynthia Knapp
Correspondent
Thermo Fisher Scientific
1 Thermo Fisher Way
Oakwood Village,  OH  44146
Correspondent Contact Cynthia Knapp
Regulation Number866.1640
Classification Product Code
NGZ  
Date Received05/18/2021
Decision Date 12/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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