SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC 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 Haemophilus/streptococcus Pneumoniae (hp) Mic Plates.

Pre-market Notification Details

Device IDK040619
510k NumberK040619
Device Name:SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC 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 Received2004-03-09
Decision Date2004-04-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384548606 K040619 000

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