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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, blood culturing
510(k) Number K032306
Device Name VERSATREK
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
982 KEYNOTE CIRCLE SUITE 6
CLEVELAND,  OH  44131
Applicant Contact NADINE M SULLIVAN
Correspondent
TREK DIAGNOSTIC SYSTEMS, INC.
982 KEYNOTE CIRCLE SUITE 6
CLEVELAND,  OH  44131
Correspondent Contact NADINE M SULLIVAN
Regulation Number866.2560
Classification Product Code
MDB  
Date Received07/25/2003
Decision Date 08/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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