Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA

Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4

PMA Number: P230016 · 2026-09-21

Decision Date2026-09-21
PMA NumberP230016
Product CodeSBL
Device ClassClass 3
Medical SpecialtyH
Regulation Number21 CFR 8
Advisory CommitteePA

Device Summary

Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies, Inc.. It received FDA 510(k) clearance on 2026-09-21. The device is classified under product code SBL. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4?

Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is Agilent Technologies, Inc..

When did Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4?

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

What is the FDA product code for Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4?

The FDA product code for Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 is SBL.

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.

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.

↑