The Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Ceftazidime/Avibactam In The Dilutions Range Of 0.015/4 - 32/4 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 The Sensititre 18-24 Hour Mic Or Breakpoint Susceptibility System With Ceftazidime/avibactam In The Dilutions Range Of 0.015/4 - 32/4 Ug/ml.

Pre-market Notification Details

Device IDK152774
510k NumberK152774
Device Name:The Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Ceftazidime/Avibactam In The Dilutions Range Of 0.015/4 - 32/4 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  
Subsequent Product CodeLRG
Subsequent Product CodeLTT
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-25
Decision Date2015-12-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384569120 K152774 000
05032384505913 K152774 000
05032384571734 K152774 000
05032384571666 K152774 000

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