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FDA 510(k) Application Details - K182690
Device Classification Name
More FDA Info for this Device
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 US
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Contact
Beth Stofka
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEO
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More FDA Info for this Product Code
Date Received
09/27/2018
Decision Date
12/21/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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