FDA PMA

染色性組織原位杂交、核酸増幅、HER2/NEU遺伝子、乳がん

PMA番号：P100024 · 2017-04-12

申請者Dako Denmark A/S

決定日2017-04-12

PMA番号P100024

製品コードNYQ

デバイスクラスクラス3

診療科U

諮問委員会PA

医療機器の概要

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.

よくある質問

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?

Chromogenic in situ hybridization、核酸増幅、HER2/NEU遺伝子、乳がんのFDA製品コードはNYQです。

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医療機器の概要

よくある質問

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