Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Imipenem-Relebactam In The Dilution Range Of 0.03/4-256/4 Ug/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 Imipenem-relebactam In The Dilution Range Of 0.03/4-256/4 Ug/ml.

Pre-market Notification Details

Device IDK192250
510k NumberK192250
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
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  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2019-10-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384529247 K192250 000
05032384571727 K192250 000

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