FDA 510(k)

Elecsys BRAHMS PCT

K号: K192815 · 2020-03-09

决定日期2020-03-09

产品代码PRI

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决定实质等同

器械摘要

Elecsys BRAHMS PCT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2020-03-09 under 510(k) number K192815. The device is classified under product code PRI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys BRAHMS PCT?

Elecsys BRAHMS PCT is a medical device that received FDA 510(k) clearance on 2020-03-09. The listed applicant is Roche Diagnostics. The 510(k) number is K192815.

When did Elecsys BRAHMS PCT receive FDA 510(k) clearance?

Elecsys BRAHMS PCT received FDA 510(k) clearance on 2020-03-09, under 510(k) number K192815.

Who is the listed applicant for Elecsys BRAHMS PCT?

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 Elecsys BRAHMS PCT?

The FDA product code for Elecsys BRAHMS PCT is PRI.

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：PRI）

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。

K220262Dimension EXL LOCI BRAHMS前白蛋白（PCT）Siemens Healthcare Diagnostics, Inc.K173927Elecsys BRAHMS PCTRoche Diagnostics K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin, Inc.K172713Lumipulse G B•R•A•H•M•S PCT 免疫反应卡，Lumipulse G B•R•A•H•M•S PCT 校准器套件Fujirebio Diagnostics,Inc.K170652ARCHITECT B.R.A.H.M.S PCT，ARCHITECT B.R.A.H.M.S PCT校准器，ARCHITECT B.R.A.H.M.S PCT控制品Fisher Diagnostics K171338B R A H M S PCT敏感KRYPTORBrahms GmbH

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