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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Panels, Test, Susceptibility, Antimicrobial
510(k) Number K024357
Device Name SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
Applicant
Trek Diagnostic Systems, Inc.
982 Keynote Cir., Suite 6
Cleveland,  OH  44131
Applicant Contact CYNTHIA C KNAPP
Correspondent
Trek Diagnostic Systems, Inc.
982 Keynote Cir., Suite 6
Cleveland,  OH  44131
Correspondent Contact CYNTHIA C KNAPP
Regulation Number866.1640
Classification Product Code
LTT  
Date Received12/30/2002
Decision Date 03/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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