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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 K242658
Device Name The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
Applicant
Thermo Fisher Scientific
1 Thermofisher Way
Oakwood Village,  OH  44146
Applicant Contact Joel Mathew
Correspondent
Thermo Fisher Scientific
1 Thermofisher Way
Oakwood Village,  OH  44146
Correspondent Contact Dylan Staats
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Codes
LRG   LTT  
Date Received09/04/2024
Decision Date 04/15/2025
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		 Yes
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