Mammaprint Ffpe

510(k) Number

K141142 ↗

FDA Product Code

NYI

Device Class

Class II

Regulation

21 CFR Part 866.6040

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• MammaPrint FFPE NGS Kit

  Class II

  FDA 510(k) K210973 Active Cleared 8 Sep 2022

• Modification To MammaPrint

  Class II

  FDA 510(k) K081092 Active Cleared 11 Dec 2009

• MammaPrint

  Class II

  FDA 510(k) K201902 Active Cleared 5 Nov 2020

• Mammaprint

  Class II

  FDA 510(k) K070675 Active Cleared 22 Jun 2007

• MammaPrint

  Class II

  FDA 510(k) K101454 Active Cleared 28 Jan 2011

• Mammaprint

  Class II

  FDA De Novo DEN070009 Active Cleared 6 Feb 2007 FDA 510(k)

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