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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fungal organisms, nucleic acid-based assay
510(k) Number K182690
Device Name ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
Applicant
GenMark Diagnostics, Incorporated
5964 La Place Court
Carlsbad,  CA  92008
Applicant Contact Beth Stofka
Correspondent
GenMark Diagnostics, Incorporated
5964 La Place Court
Carlsbad,  CA  92008
Correspondent Contact Beth Stofka
Regulation Number866.3365
Classification Product Code
PEO  
Subsequent Product Codes
PAM   PEN  
Date Received09/27/2018
Decision Date 12/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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