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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 K092445
Device Name SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
Applicant
TREK DIAGNOSTIC SYSTEMS, LTD.
982 KEYNOTE CIRCLE
SUITE 6
CLEVELAND,  OH  44131
Applicant Contact CYNTHIA C KNAPP
Correspondent
TREK DIAGNOSTIC SYSTEMS, LTD.
982 KEYNOTE CIRCLE
SUITE 6
CLEVELAND,  OH  44131
Correspondent Contact CYNTHIA C KNAPP
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Code
LRG  
Date Received08/10/2009
Decision Date 12/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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