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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram-Negative Bacteria And Associated Resistance Markers
510(k) Number K213236
Device Name ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
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 Number866.3365
Classification Product Code
PEN  
Subsequent Product Codes
PAM   PEO  
Date Received09/30/2021
Decision Date 04/27/2022
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
Predetermined Change
Control Plan Authorized		 No
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