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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name manual antimicrobial susceptibility test systems
510(k) Number K093741
Device Name SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES
Applicant
TREK DIAGNOSTIC SYSTEMS, LTD.
982 KEYNOTE CIRCLE
SUITE 6
CLEVELAND,  OH  44131
Applicant Contact Cynthia Knapp
Correspondent
TREK DIAGNOSTIC SYSTEMS, LTD.
982 KEYNOTE CIRCLE
SUITE 6
CLEVELAND,  OH  44131
Correspondent Contact Cynthia Knapp
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Code
LRG  
Date Received12/04/2009
Decision Date 02/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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