FDA 510(k)

SEFRIA吗啡口腔液体酶联免疫测定

K号: K203564 · 2021-12-22

决定日期2021-12-22

产品代码DJG

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决定实质等同

器械摘要

SEFRIA Oxycodone 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 K203564. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay?

SEFRIA Oxycodone 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 K203564.

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

SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay received FDA 510(k) clearance on 2021-12-22, under 510(k) number K203564.

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

The FDA product code for SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is DJG.

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。

K252520SEFRIA® 水合吗啡口腔液体 K232898Quantisal® 口腔液体采集装置 K223781Quantisal® II 口腔液体采集装置 K203647SEFRIA甲基苯丙胺口腔液体酶联免疫测定 K203489SEFRIA PCP 口腔液体酶联免疫测定 K200801Quantisal口腔液体收集装置

查看所有 15 个设备 →

相关器械（代码：DJG）

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。

K252684Labcorp 芬太尼尿液视觉测试Medtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA尿液多联检测Randox Laboratories Limited K253082LZI 布托啡诺 II 酶联免疫测定Lin-Zhi International, Inc.K252520SEFRIA® 水合吗啡口腔液体Immunalysis Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)测试套件 - 定性；Healgen® 免疫荧光分析仪 (OG-H180)Healgen Scientific,, LLC K251634LZI 芬太尼 III 酶联免疫测定Lin-Zhi International, Inc.

官方来源

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