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FDA PMA

SYSTEM, TEST, HER-2/NEU, IHC

PMA Number: P980018 · 2026-09-21

ApplicantAgilent Technologies Singapore (International) Pte , Ltd.
Decision Date2026-09-21
PMA NumberP980018
Product CodeMVC
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

SYSTEM, TEST, HER-2/NEU, IHC is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd.. It received FDA 510(k) clearance on 2026-09-21. The device is classified under product code MVC. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the SYSTEM, TEST, HER-2/NEU, IHC?

SYSTEM, TEST, HER-2/NEU, IHC is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd..

When did SYSTEM, TEST, HER-2/NEU, IHC receive FDA 510(k) clearance?

The clearance date for SYSTEM, TEST, HER-2/NEU, IHC can be found in the official FDA records.

Who is the listed applicant for SYSTEM, TEST, HER-2/NEU, IHC?

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

What is the FDA product code for SYSTEM, TEST, HER-2/NEU, IHC?

The FDA product code for SYSTEM, TEST, HER-2/NEU, IHC is MVC.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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