OMNYX IDP FOR HER2 MANUAL APPLICATION— 510(k) K131140

Name: FDA 510(k) clearance K131140
Creator: U.S. Food and Drug Administration
Published: 2014-04-01

Substantially Equivalent

Omnyx, LLC

FDA 510(k) clearance K131140 for OMNYX IDP FOR HER2 MANUAL APPLICATION, Substantially Equivalent on 2014-04-01. Applicant: Omnyx, LLC. Device class: 2.

Clearance details

Applicant: Omnyx, LLC
Product code: Code OEO
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2013-04-22
Decision date: 2014-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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