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FDA PMA

Somatic gene mutation detection system

PMA Number: P120014 · 2021-12-20

ApplicantbioMerieux, Inc.
Decision Date2021-12-20
PMA NumberP120014
Product CodeOWD
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Somatic gene mutation detection system is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2021-12-20. The device is classified under product code OWD. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Somatic gene mutation detection system?

Somatic gene mutation detection system is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is bioMerieux, Inc..

When did Somatic gene mutation detection system receive FDA 510(k) clearance?

The clearance date for Somatic gene mutation detection system can be found in the official FDA records.

Who is the listed applicant for Somatic gene mutation detection system?

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

What is the FDA product code for Somatic gene mutation detection system?

The FDA product code for Somatic gene mutation detection system is OWD.

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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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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