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510(k) K182690

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel by Genmark Diagnostics, Incorporated — Product Code PEO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 21, 2018
Date Received: September 27, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Fungal Organisms, Nucleic Acid-Based Assay
Device Class: Class II
Regulation Number: 866.3365
Review Panel: MI
Submission Type

A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.

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