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FDA PMA

荧光原位雜交,顯微無細胞癌激酶,基因重組

PMA 核准號:P110012 · 2026-02-18

決定日期2026-02-18
PMA 編號P110012
產品代碼OWE
器械分類3 類
醫療專科U
諮詢委員會PA

器材摘要

Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2026-02-18. The device is classified under product code OWE. It was reviewed by the PA advisory panel.

常見問題

What is the Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement?

Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Abbott Molecular, Inc..

When did Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement receive FDA 510(k) clearance?

The clearance date for Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement can be found in the official FDA records.

Who is the listed applicant for Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement?

The FDA 510(k) record lists Abbott Molecular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement?

The FDA product code for Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement is OWE.

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