FDA 510(k)

SEFRIA甲基苯丙胺口腔液体酶联免疫测定

K号: K203647 · 2021-12-22

决定日期2021-12-22

产品代码LAF

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决定实质等同

器械摘要

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K203647. 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 SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay?

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Immunalysis Corporation. The 510(k) number is K203647.

When did SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay receive FDA 510(k) clearance?

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay received FDA 510(k) clearance on 2021-12-22, under 510(k) number K203647.

Who is the listed applicant for SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay?

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

What is the FDA product code for SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay?

The FDA product code for SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is LAF.

列明Immunalysis Corporation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。

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官方来源

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