SENSITITRE 18-24 HOUR SUSECEPTIBILITY 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 18-24 Hour Suseceptibility Plates.

Pre-market Notification Details

Device IDK083606
510k NumberK083606
Device Name:SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland,  OH  44131
ContactCynthia C Knapp
CorrespondentCynthia C Knapp
TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland,  OH  44131
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-05
Decision Date2009-03-24

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