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FDA PMA

Immunohistochemistry assay, antibody, Ki-67

PMA Number: P210026 · 2026-09-11

ApplicantAgilent Technologies, Inc.
Decision Date2026-09-11
PMA NumberP210026
Product CodeQQT
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Immunohistochemistry assay, antibody, Ki-67 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 2026-09-11. The device is classified under product code QQT. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Immunohistochemistry assay, antibody, Ki-67?

Immunohistochemistry assay, antibody, Ki-67 is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Agilent Technologies, Inc..

When did Immunohistochemistry assay, antibody, Ki-67 receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry assay, antibody, Ki-67 can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry assay, antibody, Ki-67?

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, Ki-67?

The FDA product code for Immunohistochemistry assay, antibody, Ki-67 is QQT.

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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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