FDA 510(k)

ImmunalysisSEFRIAPCP口腔液酶联免疫测定

K号: K181135 · 2019-01-24

决定日期2019-01-24

产品代码LCM

决定实质等同

器械摘要

Immunalysis SEFRIA PCP 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 2019-01-24 under 510(k) number K181135. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

常见问题

What is the Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay?

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is Immunalysis Corporation. The 510(k) number is K181135.

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

Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay received FDA 510(k) clearance on 2019-01-24, under 510(k) number K181135.

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

The FDA product code for Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is LCM.

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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