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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrumentation For Clinical Multiplex Test Systems
510(k) Number K163652
Device Name ePlex Instrument
Applicant
Genmark Diagnostics, Incorporated
5964 La Pl. Ct.
Carlsbad,  CA  92008
Applicant Contact Alan Maderazo
Correspondent
Genmark Diagnostics, Incorporated
5964 La Pl. Ct.
Carlsbad,  CA  92008
Correspondent Contact Alan Maderazo
Regulation Number862.2570
Classification Product Code
NSU  
Date Received12/23/2016
Decision Date 06/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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