FDA 510(k)

Dimension EXL LOCI BRAHMS前白蛋白（PCT）

K号: K220262 · 2022-08-26

决定日期2022-08-26

产品代码PRI

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决定实质等同

器械摘要

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K220262. 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 Dimension EXL LOCI BRAHMS Procalcitonin (PCT)?

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K220262.

When did Dimension EXL LOCI BRAHMS Procalcitonin (PCT) receive FDA 510(k) clearance?

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) received FDA 510(k) clearance on 2022-08-26, under 510(k) number K220262.

Who is the listed applicant for Dimension EXL LOCI BRAHMS Procalcitonin (PCT)?

FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Dimension EXL LOCI BRAHMS Procalcitonin (PCT)?

The FDA product code for Dimension EXL LOCI BRAHMS Procalcitonin (PCT) is PRI.

列明Siemens Healthcare Diagnostics, Inc.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。

K192815Elecsys BRAHMS PCTRoche Diagnostics 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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