MAMMAPRINT FFPE— 510(k) K141142

Substantially Equivalent

Agendia

FDA 510(k) clearance K141142 for MAMMAPRINT FFPE, Substantially Equivalent on 2015-01-23. Applicant: Agendia. Device class: 2.

Clearance details

Applicant: Agendia
Product code: Code NYI
Device class: Class 2
Regulation: 21 CFR 866.6040
Advisory panel: Immunology
Date received: 2014-05-02
Decision date: 2015-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.