SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

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 Plate.

Pre-market Notification Details

Device IDK012921
510k NumberK012921
Device Name:SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
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 Received2001-08-31
Decision Date2001-11-02

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