ePlex Instrument— 510(k) K163652

Name: FDA 510(k) clearance K163652
Creator: U.S. Food and Drug Administration
Published: 2017-06-09

Substantially Equivalent

Genmark Diagnostics, Incorporated

FDA 510(k) clearance K163652 for ePlex Instrument, Substantially Equivalent on 2017-06-09. Applicant: Genmark Diagnostics, Incorporated. Device class: 2.

Clearance details

Applicant: Genmark Diagnostics, Incorporated
Product code: Code NSU
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2016-12-23
Decision date: 2017-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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