MAMMAPRINT— 510(k) K070675

Substantially Equivalent

Agendia BV

FDA 510(k) clearance K070675 for MAMMAPRINT, Substantially Equivalent on 2007-06-22. Applicant: Agendia BV. Device class: 2.

Clearance details

Applicant: Agendia BV
Product code: Code NYI
Device class: Class 2
Regulation: 21 CFR 866.6040
Advisory panel: Immunology
Date received: 2007-03-12
Decision date: 2007-06-22
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.