SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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 Hours Susceptibility Plates.

Pre-market Notification Details

Device IDK053243
510k NumberK053243
Device Name:SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
ClassificationInstrument For Auto Reader & Interpretation Of Overnight Suscept. 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 CodeLRG  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-21
Decision Date2006-01-20

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