Tina-quant 胱抑素C Gen.2
K号: K161817 · 2016-07-27
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决定日期2016-07-27
产品代码NDY
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 Cystatin C Gen.2 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 2016-07-27 under 510(k) number K161817. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tina-quant Cystatin C Gen.2?
Tina-quant Cystatin C Gen.2 is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K161817.
When did Tina-quant Cystatin C Gen.2 receive FDA 510(k) clearance?
Tina-quant Cystatin C Gen.2 received FDA 510(k) clearance on 2016-07-27, under 510(k) number K161817.
Who is the listed applicant for Tina-quant Cystatin C Gen.2?
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 Cystatin C Gen.2?
The FDA product code for Tina-quant Cystatin C Gen.2 is NDY.
相关临床试验
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列明Roche Diagnostics Operations (Rdo)为申报人的其他记录
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相关器械（代码：NDY）
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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