Idylla MSI Test
K号: K211181 · 2023-02-27
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器械摘要
Idylla MSI Test is the device name listed in this FDA 510(k) record. The listed applicant is Biocartis NV. It received FDA 510(k) clearance on 2023-02-27 under 510(k) number K211181. The device is classified under product code PZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Idylla MSI Test?
Idylla MSI Test is a medical device that received FDA 510(k) clearance on 2023-02-27. The listed applicant is Biocartis NV. The 510(k) number is K211181.
When did Idylla MSI Test receive FDA 510(k) clearance?
Idylla MSI Test received FDA 510(k) clearance on 2023-02-27, under 510(k) number K211181.
Who is the listed applicant for Idylla MSI Test?
The FDA 510(k) record lists Biocartis NV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Idylla MSI Test?
The FDA product code for Idylla MSI Test is PZJ.
相关临床试验
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相关器械（代码：PZJ）
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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