FDA 510(k)

Hemo-Lyte C 药盒

K号: K202508 · 2022-08-12

决定日期2022-08-12

产品代码KPO

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Hemo-Lyte C Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Di-Chem, Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K202508. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hemo-Lyte C Cartridge?

Hemo-Lyte C Cartridge is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Di-Chem, Inc.. The 510(k) number is K202508.

When did Hemo-Lyte C Cartridge receive FDA 510(k) clearance?

Hemo-Lyte C Cartridge received FDA 510(k) clearance on 2022-08-12, under 510(k) number K202508.

Who is the listed applicant for Hemo-Lyte C Cartridge?

The FDA 510(k) record lists Di-Chem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemo-Lyte C Cartridge?

The FDA product code for Hemo-Lyte C Cartridge is KPO.

列明Di-Chem, 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。

K171015Citryte

相关器械（代码：KPO）

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。

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。