FDA 510(k)

Diazyme DZ-Lite 总β-hCG 测试系统

K号: K163418 · 2017-08-18

决定日期2017-08-18

产品代码DHA

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

Diazyme DZ-Lite Total beta-hCG Test System is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K163418. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Diazyme DZ-Lite Total beta-hCG Test System?

Diazyme DZ-Lite Total beta-hCG Test System is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Diazyme Laboratories. The 510(k) number is K163418.

When did Diazyme DZ-Lite Total beta-hCG Test System receive FDA 510(k) clearance?

Diazyme DZ-Lite Total beta-hCG Test System received FDA 510(k) clearance on 2017-08-18, under 510(k) number K163418.

Who is the listed applicant for Diazyme DZ-Lite Total beta-hCG Test System?

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 DZ-Lite Total beta-hCG Test System?

The FDA product code for Diazyme DZ-Lite Total beta-hCG Test System is DHA.

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 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 K161646Diazyme 叶酸测定，Diazyme 叶酸校准器套装，Diazyme 叶酸控制套装 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

查看所有 8 个设备 →

相关器械（代码：DHA）

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。

K233581VITROS 免疫诊断产品总β-hCG II 试剂套装Ortho Clinical Diagnostics K223690iFlash-HCG; 化学发光免疫分析仪（型号：iFlash 3000-C）Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i 总β-hCG试剂套件，GLP系统追踪Abbott Laboratories K230790Alinity i 总β-hCG试剂套件，Alinity c 葡萄糖试剂套件，Alinity c ICT样本稀释液，Alinity ci系列Abbott Laboratories K221990Access 总βhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash 总β-hCG 测定，Diazyme DZ-Lite iFlash 1800 化学发光免疫测定分析仪Diazyme Laboratories, Inc.

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