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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
Recalls CDRH Recalls
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