Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Cefiderocol In The Dilution Range Of 0.03-64 µg/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 Cefiderocol In The Dilution Range Of 0.03-64 µg/ml.

Pre-market Notification Details

Device IDK193538
510k NumberK193538
Device Name:Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Cefiderocol In The Dilution Range Of 0.03-64 µg/ml
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village,  OH  44014 6
ContactCynthia Knapp
CorrespondentCynthia Knapp
Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village,  OH  44014 6
Product CodeJWY  
Subsequent Product CodeLRG
Subsequent Product CodeLTT
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-03-12

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