Sensititre 18 - 24 Hour MIC Or Breakpoint Susceptibility System With Dalbavancin (0.0005 - 2ug/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 Dalbavancin (0.0005 - 2ug/ml).

Pre-market Notification Details

Device IDK150236
510k NumberK150236
Device Name:Sensititre 18 - 24 Hour MIC Or Breakpoint Susceptibility System With Dalbavancin (0.0005 - 2ug/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
Subsequent Product CodeLTW
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-02
Decision Date2015-07-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384571635 K150236 000
05032384571802 K150236 000

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