ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel

K Number: K182690 · Decision Dec 21, 2018

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Device Name: ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
K Number: K182690
Device Class: FDA class 2
Clearance Type: Traditional
Regulation Number: 866.3365
Medical Specialty: Microbiology
Decision: Substantially Equivalent
Statement or Summary: Summary
Applicant: Genmark Diagnostics, Incorporated
Date Received: September 27, 2018
Decision Date: December 21, 2018
Product Code: PEO
Advisory Committee: Microbiology
Review Advisory Committee: MI
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
PEO	Fungal Organisms, Nucleic Acid-Based Assay	FDA class 2	Microbiology

Other 510(k) clearances with the same product code (PEO), ordered by most recent decision date.

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K Number	Device Name	Decision Date	Decision
K213236	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	Apr 27, 2022	Substantially Equivalent
K182619	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	Apr 12, 2019	Substantially Equivalent
K181663	ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel	Dec 20, 2018	Substantially Equivalent
K163636	ePlex Respiratory Pathogen Panel	Jun 9, 2017	Substantially Equivalent
K163652	ePlex Instrument	Jun 9, 2017	Substantially Equivalent
K152612	eSensor Warfarin Sensitivity Saliva Test	May 26, 2016	Substantially Equivalent