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FDA PMA

Prostrate cancer genes nucleic acid amplification test system

PMA Number: P100033 · 2020-07-21

ApplicantGen-Probe Incorporated
Decision Date2020-07-21
PMA NumberP100033
Product CodeOYM
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Prostrate cancer genes nucleic acid amplification test system is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe Incorporated. It received FDA 510(k) clearance on 2020-07-21. The device is classified under product code OYM. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Prostrate cancer genes nucleic acid amplification test system?

Prostrate cancer genes nucleic acid amplification test system is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is Gen-Probe Incorporated.

When did Prostrate cancer genes nucleic acid amplification test system receive FDA 510(k) clearance?

The clearance date for Prostrate cancer genes nucleic acid amplification test system can be found in the official FDA records.

Who is the listed applicant for Prostrate cancer genes nucleic acid amplification test system?

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

What is the FDA product code for Prostrate cancer genes nucleic acid amplification test system?

The FDA product code for Prostrate cancer genes nucleic acid amplification test system is OYM.

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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