FDA 510(k)

Glucose HK Gen.3，ISE 间接钠离子检测 Gen.2，Elecsys TSH，cobas pro 集成解决方案

K号: K191899 · 2019-08-16

决定日期2019-08-16

产品代码CFR

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

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K191899. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions?

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Roche Diagnostics. The 510(k) number is K191899.

When did Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions receive FDA 510(k) clearance?

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191899.

Who is the listed applicant for Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions?

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 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions?

The FDA product code for Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions is CFR.

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。

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相关器械（代码：CFR）

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。

K253490Glucose HK Gen.3；ONLINE DAT Methadone II；cobas pro 集成解决方案Roche Diagnostics K252357Glucose2Abbott Ireland K220134科博斯纯集成解决方案，葡萄糖HK Gen.3，ISE间接钠Gen.2，在线DAT美沙酮II，Elecsys促甲状腺激素Roche Diagnostics K170316ALINITY C葡萄糖试剂套件，ALINITY C系统Abbott Laboratories K153644ELITech 临床系统 GLUCOSE HK SL，ELITech 临床系统 ELICAL 2，ELITech 临床系统 ELITROL I 和 ELITROL IIElitechgroup K151487Diatron Pictus 700 临床化学分析仪，Diatron ISE，Diatron 葡萄糖己糖激酶法Diatron U.S., Inc.

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