Lp(a) Ultra
K号: K211058 · 2022-12-22
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决定日期2022-12-22
产品代码DFC
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器械摘要
Lp(a) Ultra is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K211058. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lp(a) Ultra?
Lp(a) Ultra is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K211058.
When did Lp(a) Ultra receive FDA 510(k) clearance?
Lp(a) Ultra received FDA 510(k) clearance on 2022-12-22, under 510(k) number K211058.
Who is the listed applicant for Lp(a) Ultra?
The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lp(a) Ultra?
The FDA product code for Lp(a) Ultra is DFC.
相关临床试验
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列明SENTINEL CH. SpA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。
相关器械（代码：DFC）
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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