FDA 510(k)

Sysmex 自动血凝分析仪 CS-2100i

K号: K161312 · 2016-09-01

申请人Siemens Healthcare Diagnostics Products GmbH

决定日期2016-09-01

产品代码JPA

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Sysmex Automated Blood Coagulation Analyzer CS-2100i is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161312. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sysmex Automated Blood Coagulation Analyzer CS-2100i?

Sysmex Automated Blood Coagulation Analyzer CS-2100i is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K161312.

When did Sysmex Automated Blood Coagulation Analyzer CS-2100i receive FDA 510(k) clearance?

Sysmex Automated Blood Coagulation Analyzer CS-2100i received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161312.

Who is the listed applicant for Sysmex Automated Blood Coagulation Analyzer CS-2100i?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-2100i?

The FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-2100i is JPA.

列明Siemens Healthcare Diagnostics Products GmbH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。

K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)K233663N 抗人免疫球蛋白（IgG、IgA和IgM）抗血清 K220728vWF抗原 K212559CardioPhase® hsCRP K212379N Latex FLC kappa，N Latex FLC lambda K201496N Latex FLC kappa，N Latex FLC lambda

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