Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

K-Number: K130010 · 2013-09-06

ApplicantNanostring Technologies
Decision Date2013-09-06
Product CodeNYI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nanostring Technologies. It received FDA 510(k) clearance on 2013-09-06 under 510(k) number K130010. 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 PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY?

PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY is a medical device that received FDA 510(k) clearance on 2013-09-06. The listed applicant is Nanostring Technologies. The 510(k) number is K130010.

When did PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY receive FDA 510(k) clearance?

PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY received FDA 510(k) clearance on 2013-09-06, under 510(k) number K130010.

Who is the listed applicant for PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY?

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

What is the FDA product code for PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY?

The FDA product code for PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY 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

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.K101454MAMMAPRINTAgendiaK081092MODIFICATION TO MAMMAPRINTAgendiaK080252MODIFICATION TO MAMMAPRINTAgendia BVK070675MAMMAPRINTAgendia BV

Official Source

View on FDA Database →

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

↑