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FDA PMA

Immunohistochemistry Assay, Antibody, MET

PMA Number: P240037 · 2025-07-11

ApplicantVentana Medical Systems, Inc. (Roche Tissue Diagnostics)
Decision Date2025-07-11
PMA NumberP240037
Product CodeSER
Device ClassClass 3
Medical SpecialtyH
Regulation Number21 CFR 8
Advisory CommitteePA

Device Summary

Immunohistochemistry Assay, Antibody, MET is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA 510(k) clearance on 2025-07-11. The device is classified under product code SER. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Immunohistochemistry Assay, Antibody, MET?

Immunohistochemistry Assay, Antibody, MET is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).

When did Immunohistochemistry Assay, Antibody, MET receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry Assay, Antibody, MET can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry Assay, Antibody, MET?

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

What is the FDA product code for Immunohistochemistry Assay, Antibody, MET?

The FDA product code for Immunohistochemistry Assay, Antibody, MET is SER.

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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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