SENSITITRE 18 - 24 HOURS 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 - 24 Hours Susceptibility Plates.

Pre-market Notification Details

Device IDK011803
510k NumberK011803
Device Name:SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD. SUITE 1-K Westlake,  OH  44145
ContactCynthia C Knapp
CorrespondentCynthia C Knapp
TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD. SUITE 1-K Westlake,  OH  44145
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-11
Decision Date2001-08-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384544554 K011803 000

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