肌酸激酶
K号: K160570 · 2016-05-25
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决定日期2016-05-25
产品代码JHS
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。
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器械摘要
Creatine Kinase 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 2016-05-25 under 510(k) number K160570. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Creatine Kinase?
Creatine Kinase is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K160570.
When did Creatine Kinase receive FDA 510(k) clearance?
Creatine Kinase received FDA 510(k) clearance on 2016-05-25, under 510(k) number K160570.
Who is the listed applicant for Creatine Kinase?
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 Creatine Kinase?
The FDA product code for Creatine Kinase is JHS.
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
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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