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FDA 510(k)

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

K号: K201442 · 2020-07-31

申请人Diatron Group
决定日期2020-07-31
产品代码LAF
咨询委员会TX 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is the device name listed in this FDA 510(k) record. The listed applicant is Diatron Group. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201442. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers?

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Diatron Group. The 510(k) number is K201442.

When did Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers receive FDA 510(k) clearance?

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201442.

Who is the listed applicant for Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers?

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

What is the FDA product code for Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers?

The FDA product code for Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is LAF.

相关临床试验

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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相关器械（代码：LAF）

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。

K203647SEFRIA甲基苯丙胺口腔液体酶联免疫测定Immunalysis CorporationK210212Psychemedics 同质化酶免疫测定用于检测头发中的安非他明Psychemedics CorporationK170222快速毒杯IIAmerican Bio Medica Corp.K153693Immunalysis甲基苯丙胺尿液酶联免疫测定，Immunalysis多药物校准器Immunalysis Corporation

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