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FDA PMA

Next generation sequencing oncology panel, somatic or germline variant detection system

PMA Number: P160018 · 2018-04-06

ApplicantFoundation Medicine, Inc.
Decision Date2018-04-06
PMA NumberP160018
Product CodePQP
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Next generation sequencing oncology panel, somatic or germline variant detection system is the device name listed in this FDA 510(k) record. The listed applicant is Foundation Medicine, Inc.. It received FDA 510(k) clearance on 2018-04-06. The device is classified under product code PQP. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Next generation sequencing oncology panel, somatic or germline variant detection system?

Next generation sequencing oncology panel, somatic or germline variant detection system is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Foundation Medicine, Inc..

When did Next generation sequencing oncology panel, somatic or germline variant detection system receive FDA 510(k) clearance?

The clearance date for Next generation sequencing oncology panel, somatic or germline variant detection system can be found in the official FDA records.

Who is the listed applicant for Next generation sequencing oncology panel, somatic or germline variant detection system?

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

What is the FDA product code for Next generation sequencing oncology panel, somatic or germline variant detection system?

The FDA product code for Next generation sequencing oncology panel, somatic or germline variant detection system is PQP.

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_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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.

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