CalSet IGF-1
K号: K170938 · 2017-04-26
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决定日期2017-04-26
产品代码JIT
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
CalSet IGF-1 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K170938. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CalSet IGF-1?
CalSet IGF-1 is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Roche Diagnostics. The 510(k) number is K170938.
When did CalSet IGF-1 receive FDA 510(k) clearance?
CalSet IGF-1 received FDA 510(k) clearance on 2017-04-26, under 510(k) number K170938.
Who is the listed applicant for CalSet IGF-1?
FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for CalSet IGF-1?
The FDA product code for CalSet IGF-1 is JIT.
相关临床试验
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。
列明Roche Diagnostics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：JIT）
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。
K171168VITROS 免疫诊断产品 胰岛素校准器Ortho Clinical DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163546Lumipulse G 孕酮-N 校准器Fujirebio Diagnostics,Inc.K163534Lumipulse G FSH-N 校准器Fujirebio Diagnostics,Inc.K163544Lumipulse G 乳糜素Fujirebio Diagnostics,Inc.K163521Lumipulse G LH 校准器Fujirebio Diagnostics,Inc.
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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