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FDA PMA

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

PMA Number: P100027 · 2024-01-26

ApplicantVentana Medical Systems, Inc.
Decision Date2024-01-26
PMA NumberP100027
Product CodeNYQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-01-26. The device is classified under product code NYQ. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Ventana Medical Systems, Inc..

When did Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer receive FDA 510(k) clearance?

The clearance date for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer can be found in the official FDA records.

Who is the listed applicant for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

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

What is the FDA product code for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

The FDA product code for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is NYQ.

Related Clinical Trials

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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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