FDA 510(k)

Cryocheck Hex LA

K号: K193556 · 2020-10-23

决定日期2020-10-23

产品代码GFO

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

Cryocheck Hex LA is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K193556. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cryocheck Hex LA?

Cryocheck Hex LA is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Precision Biologic. The 510(k) number is K193556.

When did Cryocheck Hex LA receive FDA 510(k) clearance?

Cryocheck Hex LA received FDA 510(k) clearance on 2020-10-23, under 510(k) number K193556.

Who is the listed applicant for Cryocheck Hex LA?

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

What is the FDA product code for Cryocheck Hex LA?

The FDA product code for Cryocheck Hex LA is GFO.

列明Precision Biologic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。

K193204Cryocheck 酶联因子VIII

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。