MAMMAPRINT— 510(k) K101454

Substantially Equivalent

Agendia

FDA 510(k) clearance K101454 for MAMMAPRINT, Substantially Equivalent on 2011-01-28. 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: 2010-05-25
Decision date: 2011-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

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