Lumpipulse G CA19-9-N
K号: K191973 · 2019-10-22
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决定日期2019-10-22
产品代码NIG
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器械摘要
Lumpipulse G CA19-9-N is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Dianostics, Inc.. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K191973. The device is classified under product code NIG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lumpipulse G CA19-9-N?
Lumpipulse G CA19-9-N is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Fujirebio Dianostics, Inc.. The 510(k) number is K191973.
When did Lumpipulse G CA19-9-N receive FDA 510(k) clearance?
Lumpipulse G CA19-9-N received FDA 510(k) clearance on 2019-10-22, under 510(k) number K191973.
Who is the listed applicant for Lumpipulse G CA19-9-N?
The FDA 510(k) record lists Fujirebio Dianostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lumpipulse G CA19-9-N?
The FDA product code for Lumpipulse G CA19-9-N is NIG.
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相关器械（代码：NIG）
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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