PATHFAST®hs-cTnI-II
K号: K231974 · 2024-03-20
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决定日期2024-03-20
产品代码MMI
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
PATHFAST®hs-cTnI-II is the device name listed in this FDA 510(k) record. The listed applicant is Phc Corporation. It received FDA 510(k) clearance on 2024-03-20 under 510(k) number K231974. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PATHFAST®hs-cTnI-II?
PATHFAST®hs-cTnI-II is a medical device that received FDA 510(k) clearance on 2024-03-20. The listed applicant is Phc Corporation. The 510(k) number is K231974.
When did PATHFAST®hs-cTnI-II receive FDA 510(k) clearance?
PATHFAST®hs-cTnI-II received FDA 510(k) clearance on 2024-03-20, under 510(k) number K231974.
Who is the listed applicant for PATHFAST®hs-cTnI-II?
The FDA 510(k) record lists Phc Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PATHFAST®hs-cTnI-II?
The FDA product code for PATHFAST®hs-cTnI-II is MMI.
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：MMI）
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。
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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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