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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 Thermofisher Way
Oakwood Village,  OH  44146
Applicant Contact Cynthia Knapp
Correspondent
Thermo Fisher Scientific
1 Thermofisher 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
Predetermined Change
Control Plan Authorized		 No
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