EPlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

Gram-positive Bacteria And Their Resistance Markers

GenMark Diagnostics, Incorporated

The following data is part of a premarket notification filed by Genmark Diagnostics, Incorporated with the FDA for Eplex Blood Culture Identification Panel - Gram Positive (bcid-gp) Panel.

Pre-market Notification Details

Device IDK181663
510k NumberK181663
Device Name:EPlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
ClassificationGram-positive Bacteria And Their Resistance Markers
Applicant GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad,  CA  92008
ContactAlan Maderazo
CorrespondentAlan Maderazo
GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad,  CA  92008
Product CodePAM  
Subsequent Product CodePEN
Subsequent Product CodePEO
CFR Regulation Number866.3365 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-25
Decision Date2018-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857167005337 K181663 000
00857167005320 K181663 000

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