CellDx-Tissue
K号: K260235 · 2026-05-12
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决定日期2026-05-12
产品代码PZM
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。
决定实质等同
器械摘要
CellDx-Tissue is the device name listed in this FDA 510(k) record. The listed applicant is Datar Cancer Genetics Private Limited. It received FDA 510(k) clearance on 2026-05-12 under 510(k) number K260235. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CellDx-Tissue?
CellDx-Tissue is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Datar Cancer Genetics Private Limited. The 510(k) number is K260235.
When did CellDx-Tissue receive FDA 510(k) clearance?
CellDx-Tissue received FDA 510(k) clearance on 2026-05-12, under 510(k) number K260235.
Who is the listed applicant for CellDx-Tissue?
The FDA 510(k) record lists Datar Cancer Genetics Private Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CellDx-Tissue?
The FDA product code for CellDx-Tissue is PZM.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：PZM）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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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