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FDA 510(k)

MAMMAPRINT

K-Number: K101454 · 2011-01-28

ApplicantAgendia
Decision Date2011-01-28
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. It received FDA 510(k) clearance on 2011-01-28 under 510(k) number K101454. 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 2011-01-28. The listed applicant is Agendia. The 510(k) number is K101454.

When did MAMMAPRINT receive FDA 510(k) clearance?

MAMMAPRINT received FDA 510(k) clearance on 2011-01-28, under 510(k) number K101454.

Who is the listed applicant for 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 MAMMAPRINT?

The FDA product code for 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K081092MODIFICATION TO MAMMAPRINT

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 TechnologiesK081092MODIFICATION TO MAMMAPRINTAgendiaK080252MODIFICATION 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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