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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 K202612
Device Name Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
Applicant
Thermofisher Scientific
One Thermo Fisher Way
Oakwood Village,  OH  44146
Applicant Contact Cynthia Knapp
Correspondent
Thermofisher Scientific
One Thermo Fisher Way
Oakwood Village,  OH  44146
Correspondent Contact Cynthia Knapp
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Codes
LRG   LTT  
Date Received09/09/2020
Decision Date 07/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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