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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 K193538
Device Name Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/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  
Subsequent Product Codes
LRG   LTT  
Date Received12/20/2019
Decision Date 03/12/2020
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
Recalls CDRH Recalls
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