FDA 510(k)

LZI 美沙酮代谢物酶联免疫测定，LZI 美沙酮代谢物 (100 和 300) 校准品

K号: K170416 · 2017-06-26

决定日期2017-06-26

产品代码DJR

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决定实质等同

器械摘要

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2017-06-26 under 510(k) number K170416. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators?

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is a medical device that received FDA 510(k) clearance on 2017-06-26. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K170416.

When did LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators receive FDA 510(k) clearance?

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators received FDA 510(k) clearance on 2017-06-26, under 510(k) number K170416.

Who is the listed applicant for LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators?

The FDA product code for LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is DJR.

列明Lin-Zhi International, Inc.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。

K253082LZI 布托啡诺 II 酶联免疫测定 K251634LZI 芬太尼 III 酶联免疫测定 K202007LZI 氧可酮 III 酶联免疫测定 K201938LZI 芬太尼 II 酶联免疫测定 K201223LZI 曲马多酶联免疫测定 K192299LZI 尼古丁 II 酶联免疫测定

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官方来源

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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。