原位荧光杂交，间变性淋巴瘤激酶，基因重排
PMA编号：P110012 · 2026-02-18
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决定日期2026-02-18
PMA 编号P110012
产品代码OWE
设备分类第3类
医疗专科U
咨询委员会PA
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器械摘要
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.
常见问题
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.
相关临床试验
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官方来源
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