FDA 510(k)

Albumin BCP

K号: K193001 · 2019-12-19

决定日期2019-12-19

产品代码CJW

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决定实质等同

器械摘要

Albumin BCP is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K193001. The device is classified under product code CJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Albumin BCP?

Albumin BCP is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K193001.

When did Albumin BCP receive FDA 510(k) clearance?

Albumin BCP received FDA 510(k) clearance on 2019-12-19, under 510(k) number K193001.

Who is the listed applicant for Albumin BCP?

The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Albumin BCP?

The FDA product code for Albumin BCP is CJW.

列明SENTINEL CH. SpA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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