MammaPrint FFPE NGS Kit— 510(k) K210973

Substantially Equivalent

Agendia, Inc.

FDA 510(k) clearance K210973 for MammaPrint FFPE NGS Kit, Substantially Equivalent on 2022-09-08. Applicant: Agendia, Inc.. Device class: 2.

Clearance details

Applicant: Agendia, Inc.
Product code: Code NYI
Device class: Class 2
Regulation: 21 CFR 866.6040
Advisory panel: Immunology
Date received: 2021-03-31
Decision date: 2022-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvina, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NYI

K201902 — MammaPrint2020-11-05
K141142 — MAMMAPRINT FFPE2015-01-23
K141771 — PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY2014-11-07
K130010 — PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY2013-09-06
K101454 — MAMMAPRINT2011-01-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.