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FDA PMA

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

PMA Number: P100024 · 2017-04-12

ApplicantDako Denmark A/S
Decision Date2017-04-12
PMA NumberP100024
Product CodeNYQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is the device name listed in this FDA 510(k) record. The listed applicant is Dako Denmark A/S. It received FDA 510(k) clearance on 2017-04-12. The device is classified under product code NYQ. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Dako Denmark A/S.

When did Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer receive FDA 510(k) clearance?

The clearance date for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer can be found in the official FDA records.

Who is the listed applicant for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

The FDA 510(k) record lists Dako Denmark A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer?

The FDA product code for Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer is NYQ.

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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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