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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 K231988
Device Name Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
Applicant
Thermo Fisher Scientific
One Thermo Fisher Way
Oakwood Village,  OH  44146
Applicant Contact Joel Mathew
Correspondent
Thermo Fisher Scientific
One Thermo Fisher Way
Oakwood Village,  OH  44146
Correspondent Contact Dylan Staats
Regulation Number866.1640
Classification Product Code
JWY  
Date Received07/05/2023
Decision Date 08/30/2023
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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