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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 K081520
Device Name SENSITITRE VIZION
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
JWY  
Date Received05/30/2008
Decision Date 10/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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