HemosIL纤维蛋白原-C；HemosIL纤维蛋白原-C XL
K号: K251968 · 2025-07-24
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决定日期2025-07-24
产品代码KQJ
咨询委员会HE
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决定实质等同
器械摘要
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL 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 2025-07-24 under 510(k) number K251968. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL?
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is Instrumentation Laboratory (IL) Co.. The 510(k) number is K251968.
When did HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL receive FDA 510(k) clearance?
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL received FDA 510(k) clearance on 2025-07-24, under 510(k) number K251968.
Who is the listed applicant for HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL?
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 Fibrinogen-C; HemosIL Fibrinogen-C XL?
The FDA product code for HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL is KQJ.
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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