SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

Panels, Test, Susceptibility, Antimicrobial

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 Hours Susceptibility Plates.

Pre-market Notification Details

Device IDK024353
510k NumberK024353
Device Name:SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
ClassificationPanels, Test, Susceptibility, Antimicrobial
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 CodeLTT  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-30
Decision Date2003-03-06

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