ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel— 510(k) K182690

Name: FDA 510(k) clearance K182690
Creator: U.S. Food and Drug Administration
Published: 2018-12-21

Substantially Equivalent

Genmark Diagnostics, Incorporated

FDA 510(k) clearance K182690 for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel, Substantially Equivalent on 2018-12-21. Applicant: Genmark Diagnostics, Incorporated. Device class: 2.

Clearance details

Applicant: Genmark Diagnostics, Incorporated
Product code: Code PEO
Device class: Class 2
Regulation: 21 CFR 866.3365
Advisory panel: Microbiology
Date received: 2018-09-27
Decision date: 2018-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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