FDA 510(k)

MammaPrint

K-Number: K201902 · 2020-11-05

Decision Date2020-11-05

Product CodeNYI

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

MammaPrint is the device name listed in this FDA 510(k) record. The listed applicant is Agendia, Inc.. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K201902. The device is classified under product code NYI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MammaPrint?

MammaPrint is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Agendia, Inc.. The 510(k) number is K201902.

When did MammaPrint receive FDA 510(k) clearance?

MammaPrint received FDA 510(k) clearance on 2020-11-05, under 510(k) number K201902.

Who is the listed applicant for MammaPrint?

The FDA 510(k) record lists Agendia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MammaPrint?

The FDA product code for MammaPrint is NYI.

Other records listing Agendia, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210973MammaPrint FFPE NGS Kit

Related Devices (Code: NYI)

K210973MammaPrint FFPE NGS KitAgendia, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.