Sensititre 18-24 Hour MIC Breakpoint Susceptibility System With Plazomicin In The Dilution Range Of 0.06-128 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 Breakpoint Susceptibility System With Plazomicin In The Dilution Range Of 0.06-128 Ug/ml.

Pre-market Notification Details

Device IDK181946
510k NumberK181946
Device Name:Sensititre 18-24 Hour MIC Breakpoint Susceptibility System With Plazomicin In The Dilution Range Of 0.06-128 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  
Subsequent Product CodeLRG
Subsequent Product CodeLTT
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-20
Decision Date2018-08-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.