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FDA PMA

Immunohistochemistry assay, antibody, epidermal growth factor receptor

PMA Number: P030044 · 2019-03-13

ApplicantAgilent Technologies, Inc.
Decision Date2019-03-13
PMA NumberP030044
Product CodeNQF
Device ClassClass 3
Medical SpecialtyH
Regulation Number21 CFR 8
Advisory CommitteePA

Device Summary

Immunohistochemistry assay, antibody, epidermal growth factor receptor 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 2019-03-13. The device is classified under product code NQF. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Immunohistochemistry assay, antibody, epidermal growth factor receptor?

Immunohistochemistry assay, antibody, epidermal growth factor receptor is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Agilent Technologies, Inc..

When did Immunohistochemistry assay, antibody, epidermal growth factor receptor receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry assay, antibody, epidermal growth factor receptor can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry assay, antibody, epidermal growth factor receptor?

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, epidermal growth factor receptor?

The FDA product code for Immunohistochemistry assay, antibody, epidermal growth factor receptor is NQF.

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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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