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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 K223844
Device Name Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
Applicant
Thermo Fisher Scientific
One Thermo Fisher Way
Oakwood Village,  OH  44146
Applicant Contact Cynthia Knapp
Correspondent
Thermo Fisher Scientific
One Thermo Fisher Way
Oakwood Village,  OH  44146
Correspondent Contact Cynthia Knapp
Regulation Number866.1640
Classification Product Code
JWY  
Date Received12/22/2022
Decision Date 03/21/2023
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
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