SENSITITRE 18-24HR SUSCEPTIBILITY PLATES

Manual Antimicrobial Susceptibility Test Systems

TREK DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Sensititre 18-24hr Susceptibility Plates.

Pre-market Notification Details

Device IDK093865
510k NumberK093865
Device Name:SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE Cleveland,  OH  44131
ContactCindy Knapp
CorrespondentCindy Knapp
TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE Cleveland,  OH  44131
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-16
Decision Date2010-02-17
Summary:summary

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