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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Transport, Aerobic
510(k) Number K983244
Device Name SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
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 Number866.2900
Classification Product Code
JTW  
Date Received09/16/1998
Decision Date 11/30/1998
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
Recalls CDRH Recalls
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