FDA 510(k)

Randox 钙 (Ca)

K号: K182042 · 2018-10-23

决定日期2018-10-23

产品代码CJY

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

Randox Calcium (Ca) is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2018-10-23 under 510(k) number K182042. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Randox Calcium (Ca)?

Randox Calcium (Ca) is a medical device that received FDA 510(k) clearance on 2018-10-23. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K182042.

When did Randox Calcium (Ca) receive FDA 510(k) clearance?

Randox Calcium (Ca) received FDA 510(k) clearance on 2018-10-23, under 510(k) number K182042.

Who is the listed applicant for Randox Calcium (Ca)?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Randox Calcium (Ca)?

The FDA product code for Randox Calcium (Ca) is CJY.

列明Randox Laboratories, Ltd.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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