HemosIL因子V莱登（APC抵抗V）
K号: K260551 · 2026-03-20
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决定日期2026-03-20
产品代码GGW
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
HemosIL Factor V Leiden (APC Resistance V) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory (IL) Co.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K260551. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HemosIL Factor V Leiden (APC Resistance V)?
HemosIL Factor V Leiden (APC Resistance V) is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Instrumentation Laboratory (IL) Co.. The 510(k) number is K260551.
When did HemosIL Factor V Leiden (APC Resistance V) receive FDA 510(k) clearance?
HemosIL Factor V Leiden (APC Resistance V) received FDA 510(k) clearance on 2026-03-20, under 510(k) number K260551.
Who is the listed applicant for HemosIL Factor V Leiden (APC Resistance V)?
The FDA 510(k) record lists Instrumentation Laboratory (IL) Co. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HemosIL Factor V Leiden (APC Resistance V)?
The FDA product code for HemosIL Factor V Leiden (APC Resistance V) is GGW.
相关临床试验
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列明Instrumentation Laboratory (IL) Co.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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