Tina-quant 血红蛋白A1cDx 通用.3
K号: K193053 · 2020-03-26
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决定日期2020-03-26
产品代码PDJ
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
Tina-quant Hemoglobin A1cDx Gen.3 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K193053. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tina-quant Hemoglobin A1cDx Gen.3?
Tina-quant Hemoglobin A1cDx Gen.3 is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K193053.
When did Tina-quant Hemoglobin A1cDx Gen.3 receive FDA 510(k) clearance?
Tina-quant Hemoglobin A1cDx Gen.3 received FDA 510(k) clearance on 2020-03-26, under 510(k) number K193053.
Who is the listed applicant for Tina-quant Hemoglobin A1cDx Gen.3?
The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tina-quant Hemoglobin A1cDx Gen.3?
The FDA product code for Tina-quant Hemoglobin A1cDx Gen.3 is PDJ.
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 Operations (Rdo)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：PDJ）
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。
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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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