FDA 510(k)

Diazyme 叶酸测定，Diazyme 叶酸校准器套装，Diazyme 叶酸控制套装

K号: K161646 · 2016-11-04

决定日期2016-11-04

产品代码CGN

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决定实质等同

器械摘要

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161646. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set?

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Diazyme Laboratories. The 510(k) number is K161646.

When did Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set receive FDA 510(k) clearance?

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161646.

Who is the listed applicant for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set?

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

What is the FDA product code for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set?

The FDA product code for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is CGN.

列明Diazyme Laboratories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。

K172992Diazyme EZ 维生素D测定 K163418Diazyme DZ-Lite 总β-hCG 测试系统 K162297Diazyme 前降钙素（PCT）测定，Diazyme 前降钙素（PCT）校准器套装，Diazyme 前降钙素（PCT）控制套装 K160762Diazyme 直接HbA1c测定（酶法，板载溶解），Diazyme 直接HbA1c测定校准器套装，Diazyme 直接HbA1c测定控制套装 K153394Diazyme 人κ游离轻链测定，Diazyme 人λ游离轻链测定，Diazyme 人κ/λ游离轻链校准器，Diazyme 人κ/λ游离轻链校准器 K161721Diazyme 维生素B12测定，Diazyme 维生素B12校准器套装，Diazyme 维生素B12控制套装

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官方来源

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