MAMMAPRINT FFPE— 510(k) K141142

Substantially Equivalent

Agendia

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

Clearance details

Applicant: Agendia
Product code: Code NYI
Advisory panel: Immunology
Date received: 2014-05-02
Decision date: 2015-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

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