Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Lefamulin In The Dilution Range Of 0.008-16ug/ml

Manual Antimicrobial Susceptibility Test Systems

Thermo Fisher Scientific

The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Sensititre 18-24 Hour Mic Or Breakpoint Susceptibility System With Lefamulin In The Dilution Range Of 0.008-16ug/ml.

Pre-market Notification Details

Device IDK192729
501k NumberK192729
Device Name:Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Lefamulin In The Dilution Range Of 0.008-16ug/ml
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant Thermo Fisher Scientific One Thermo Fisher Way Oakwood Village,  OH  44146
ContactCynthia Knapp
CorrespondentCynthia Knapp
Thermo Fisher Scientific One Thermo Fisher Way Oakwood Village,  OH  44146
Product CodeJWY  
Subsequent Product CodeLRG
Subsequent Product CodeLTT
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
501k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-27
Decision Date2019-11-06

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