FDA 510(k)

Audit MicroControls Linearity DROP LQ 血糖

K号: K161874 · 2016-08-10

决定日期2016-08-10

产品代码JJX

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

Audit MicroControls Linearity DROP LQ Blood Glucose is the device name listed in this FDA 510(k) record. The listed applicant is Aalto Scientific, Ltd.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K161874. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Audit MicroControls Linearity DROP LQ Blood Glucose?

Audit MicroControls Linearity DROP LQ Blood Glucose is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Aalto Scientific, Ltd.. The 510(k) number is K161874.

When did Audit MicroControls Linearity DROP LQ Blood Glucose receive FDA 510(k) clearance?

Audit MicroControls Linearity DROP LQ Blood Glucose received FDA 510(k) clearance on 2016-08-10, under 510(k) number K161874.

Who is the listed applicant for Audit MicroControls Linearity DROP LQ Blood Glucose?

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

What is the FDA product code for Audit MicroControls Linearity DROP LQ Blood Glucose?

The FDA product code for Audit MicroControls Linearity DROP LQ Blood Glucose is JJX.

列明Aalto Scientific, 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。

K163629Audit MicroControls Linearity FD 肿瘤标志物 II

官方来源

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