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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gram-positive bacteria and their resistance markers
510(k) Number K181663
Device Name ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
Applicant
GenMark Diagnostics, Incorporated
5964 La Place Court
carlsbad,  CA  92008
Applicant Contact alan maderazo
Correspondent
GenMark Diagnostics, Incorporated
5964 La Place Court
carlsbad,  CA  92008
Correspondent Contact alan maderazo
Regulation Number866.3365
Classification Product Code
PAM  
Subsequent Product Codes
PEN   PEO  
Date Received06/25/2018
Decision Date 12/20/2018
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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