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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 K192250
Device Name Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
Applicant
Thermo Fisher Scientific
1 Thermo Fisher Way
oakwood village,  OH  44014 6
Applicant Contact cynthia knapp
Correspondent
Thermo Fisher Scientific
1 Thermo Fisher Way
oakwood village,  OH  44014 6
Correspondent Contact cynthia knapp
Regulation Number866.1640
Classification Product Code
JWY  
Date Received08/19/2019
Decision Date 10/16/2019
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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