Sensititre Susceptibility Plates

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 Susceptibility Plates.

Pre-market Notification Details

Device IDK143288
510k NumberK143288
Device Name:Sensititre Susceptibility Plates
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant THERMO FISHER SCIENTIFIC 1 THERMO FISHER WAY Oakwood Village,  OH  44146
ContactCynthia Knapp
CorrespondentCynthia Knapp
THERMO FISHER SCIENTIFIC 1 THERMO FISHER WAY Oakwood Village,  OH  44146
Product CodeJWY  
Subsequent Product CodeLRG
Subsequent Product CodeLTT
Subsequent Product CodeLTW
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-17
Decision Date2015-04-01

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