免疫细胞化学检测，p16/Ki-67
PMA编号：P190024 · 2025-09-04
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决定日期2025-09-04
PMA 编号P190024
产品代码QKF
设备分类第3类
医疗专科H
法规编号21 CFR 8
咨询委员会PA
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
器械摘要
Immunocytochemistry assay, p16/Ki-67 is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-09-04. The device is classified under product code QKF. It was reviewed by the PA advisory panel.
常见问题
What is the Immunocytochemistry assay, p16/Ki-67?
Immunocytochemistry assay, p16/Ki-67 is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Ventana Medical Systems, Inc..
When did Immunocytochemistry assay, p16/Ki-67 receive FDA 510(k) clearance?
The clearance date for Immunocytochemistry assay, p16/Ki-67 can be found in the official FDA records.
Who is the listed applicant for Immunocytochemistry assay, p16/Ki-67?
The FDA 510(k) record lists Ventana Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Immunocytochemistry assay, p16/Ki-67?
The FDA product code for Immunocytochemistry assay, p16/Ki-67 is QKF.
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官方来源
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