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FDA PMA

Immunohistochemistry assay, antibody, anaplastic lymphoma kinase

PMA Number: P140025 · 2025-06-20

ApplicantVentana Medical Systems, Inc.
Decision Date2025-06-20
PMA NumberP140025
Product CodePKW
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Immunohistochemistry assay, antibody, anaplastic lymphoma kinase 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 2025-06-20. The device is classified under product code PKW. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Immunohistochemistry assay, antibody, anaplastic lymphoma kinase?

Immunohistochemistry assay, antibody, anaplastic lymphoma kinase is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Ventana Medical Systems, Inc..

When did Immunohistochemistry assay, antibody, anaplastic lymphoma kinase receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry assay, antibody, anaplastic lymphoma kinase can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry assay, antibody, anaplastic lymphoma kinase?

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 Immunohistochemistry assay, antibody, anaplastic lymphoma kinase?

The FDA product code for Immunohistochemistry assay, antibody, anaplastic lymphoma kinase is PKW.

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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