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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 K133038
Device Name SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
Applicant
TREK DIAGNOSTIC SYSTEMS
1 Thermo Fisher Way
oakwood village,  OH  44146
Applicant Contact cindy knapp
Correspondent
TREK DIAGNOSTIC SYSTEMS
1 Thermo Fisher Way
oakwood village,  OH  44146
Correspondent Contact cindy knapp
Regulation Number866.1640
Classification Product Code
NGZ  
Date Received09/26/2013
Decision Date 01/31/2014
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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