FDA 510(k)

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

K号: K220134 · 2022-09-16

决定日期2022-09-16

产品代码CFR

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决定实质等同

器械摘要

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K220134. 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 cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH?

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Roche Diagnostics. The 510(k) number is K220134.

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

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH received FDA 510(k) clearance on 2022-09-16, under 510(k) number K220134.

Who is the listed applicant for cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH?

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 cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH?

The FDA product code for cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH 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。

K261686Elecsys 磷酸-Tau（217P）血浆 K252323科博斯脉搏血糖监测系统 K252280Elecsys 抗-SARS-CoV-2 S K260049Elecsys Anti-HBc IgM K260048Elecsys Anti-HAV IgM K260046Elecsys Anti-HBc II

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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 K191899Glucose HK Gen.3，ISE 间接钠离子检测 Gen.2，Elecsys TSH，cobas pro 集成解决方案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.

官方来源

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