MODIFICATION TO MAMMAPRINT— 510(k) K080252

Substantially Equivalent

Agendia BV

FDA 510(k) clearance K080252 for MODIFICATION TO MAMMAPRINT, Substantially Equivalent on 2008-07-21. Applicant: Agendia BV.

Clearance details

Applicant: Agendia BV
Product code: Code NYI
Advisory panel: Immunology
Date received: 2008-01-31
Decision date: 2008-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

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