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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K143526
Device Name The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
Applicant
Thermo Fisher Scientific
1 Thermo Fisher Way
Oakwood Village,  OH  44014
Applicant Contact Cynthia Knapp
Correspondent
Thermo Fisher Scientific
1 Thermo Fisher Way
Oakwood Village,  OH  44014
Correspondent Contact Cynthia Knapp
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Codes
LRG   LTT  
Date Received12/12/2014
Decision Date 03/05/2015
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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