Immunohistochemistry Assay, Antibody
PMA编号：P250031 · 2026-06-12
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决定日期2026-06-12
PMA 编号P250031
产品代码SHF
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
Immunohistochemistry Assay, Antibody is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA 510(k) clearance on 2026-06-12. The device is classified under product code SHF. It was reviewed by the PA advisory panel.
常见问题
What is the Immunohistochemistry Assay, Antibody?
Immunohistochemistry Assay, Antibody is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).
When did Immunohistochemistry Assay, Antibody receive FDA 510(k) clearance?
The clearance date for Immunohistochemistry Assay, Antibody can be found in the official FDA records.
Who is the listed applicant for Immunohistochemistry Assay, Antibody?
The FDA 510(k) record lists Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Immunohistochemistry Assay, Antibody?
The FDA product code for Immunohistochemistry Assay, Antibody is SHF.
相关临床试验
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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