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FDA 510(k)

MODIFICATION TO MAMMAPRINT

K-Number: K081092 · 2009-12-11

ApplicantAgendia
Decision Date2009-12-11
Product CodeNYI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MAMMAPRINT is the device name listed in this FDA 510(k) record. The listed applicant is Agendia. It received FDA 510(k) clearance on 2009-12-11 under 510(k) number K081092. 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 MODIFICATION TO MAMMAPRINT?

MODIFICATION TO MAMMAPRINT is a medical device that received FDA 510(k) clearance on 2009-12-11. The listed applicant is Agendia. The 510(k) number is K081092.

When did MODIFICATION TO MAMMAPRINT receive FDA 510(k) clearance?

MODIFICATION TO MAMMAPRINT received FDA 510(k) clearance on 2009-12-11, under 510(k) number K081092.

Who is the listed applicant for MODIFICATION TO MAMMAPRINT?

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

What is the FDA product code for MODIFICATION TO MAMMAPRINT?

The FDA product code for MODIFICATION TO MAMMAPRINT is NYI.

Related Clinical Trials

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.

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Other records listing Agendia 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.

K101454MAMMAPRINT

Related Devices (Code: NYI)

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 KitAgendia, Inc.K201902MammaPrintAgendia, Inc.K130010PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAYNanostring TechnologiesK101454MAMMAPRINTAgendiaK080252MODIFICATION TO MAMMAPRINTAgendia BVK070675MAMMAPRINTAgendia BV

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.

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