SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES

Manual Antimicrobial Susceptibility Test Systems

TREK DIAGNOSTIC SYSTEMS, LTD.

The following data is part of a premarket notification filed by Trek Diagnostic Systems, Ltd. with the FDA for Sensitive Haemophilus Influenzae, Streptococcus Pneumonia, (hp) Mic Susceptibility Plates.

Pre-market Notification Details

Device IDK093741
510k NumberK093741
Device Name:SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland,  OH  44131
ContactCynthia Knapp
CorrespondentCynthia Knapp
TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland,  OH  44131
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-04
Decision Date2010-02-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.