INNOVANCE 抗凝血酶
K号: K242952 · 2025-03-28
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决定日期2025-03-28
产品代码JBQ
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
INNOVANCE Antithrombin is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. It received FDA 510(k) clearance on 2025-03-28 under 510(k) number K242952. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the INNOVANCE Antithrombin?
INNOVANCE Antithrombin is a medical device that received FDA 510(k) clearance on 2025-03-28. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. The 510(k) number is K242952.
When did INNOVANCE Antithrombin receive FDA 510(k) clearance?
INNOVANCE Antithrombin received FDA 510(k) clearance on 2025-03-28, under 510(k) number K242952.
Who is the listed applicant for INNOVANCE Antithrombin?
FDA 510(k)记录显示，西门子医疗诊断产品有限公司为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for INNOVANCE Antithrombin?
The FDA product code for INNOVANCE Antithrombin is JBQ.
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。
列明Siemens Healthcare Diagnostic Products GmbH为申报人的其他记录
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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