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FDA PMA

Immunohistochemistry assay, antibody, claudin 18

PMA Number: P230018 · 2025-06-20

ApplicantVentana Medical Systems, Inc.
Decision Date2025-06-20
PMA NumberP230018
Product CodeQZJ
Device ClassClass 3
Medical SpecialtyH
Regulation Number21 CFR 8
Advisory CommitteePA

Device Summary

Immunohistochemistry assay, antibody, claudin 18 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 QZJ. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Immunohistochemistry assay, antibody, claudin 18?

Immunohistochemistry assay, antibody, claudin 18 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, claudin 18 receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry assay, antibody, claudin 18 can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry assay, antibody, claudin 18?

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, claudin 18?

The FDA product code for Immunohistochemistry assay, antibody, claudin 18 is QZJ.

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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