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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 K073424
Device Name SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
982 KEYNOTE CIRCLE SUITE 6
CLEVELAND,  OH  44131
Applicant Contact CYNTHIA C KNAPP
Correspondent
TREK DIAGNOSTIC SYSTEMS, INC.
982 KEYNOTE CIRCLE SUITE 6
CLEVELAND,  OH  44131
Correspondent Contact CYNTHIA C KNAPP
Regulation Number866.1640
Classification Product Code
JWY  
Date Received12/05/2007
Decision Date 01/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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