FDA 510(k)

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

K号: K170901 · 2018-04-13

决定日期2018-04-13

产品代码CIX

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决定实质等同

器械摘要

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 is the device name listed in this FDA 510(k) record. The listed applicant is Biosystems S.A.. It received FDA 510(k) clearance on 2018-04-13 under 510(k) number K170901. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400?

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Biosystems S.A.. The 510(k) number is K170901.

When did ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 receive FDA 510(k) clearance?

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 received FDA 510(k) clearance on 2018-04-13, under 510(k) number K170901.

Who is the listed applicant for ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400?

The FDA 510(k) record lists Biosystems S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400?

The FDA product code for ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 is CIX.

列明Biosystems S.A.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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