FDA 510(k)

N Latex Cystatin C; N 蛋白质标准 UY

K号: K171072 · 2017-05-12

申请人Siemens Healthcare Diagnostics Products GmbH

决定日期2017-05-12

产品代码NDY

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

N Latex Cystatin C; N Protein Standard UY 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 2017-05-12 under 510(k) number K171072. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the N Latex Cystatin C; N Protein Standard UY?

N Latex Cystatin C; N Protein Standard UY is a medical device that received FDA 510(k) clearance on 2017-05-12. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K171072.

When did N Latex Cystatin C; N Protein Standard UY receive FDA 510(k) clearance?

N Latex Cystatin C; N Protein Standard UY received FDA 510(k) clearance on 2017-05-12, under 510(k) number K171072.

Who is the listed applicant for N Latex Cystatin C; N Protein Standard UY?

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 N Latex Cystatin C; N Protein Standard UY?

The FDA product code for N Latex Cystatin C; N Protein Standard UY is NDY.

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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官方来源

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