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

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.

Clearance details

Applicant: Omnyx, LLC
Product code: Code OEO
Advisory panel: Hematology
Date received: 2013-04-22
Decision date: 2014-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

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