FDA 510(k)

Pointe科学可卡因代谢物酶免疫测定

K号: K191638 · 2020-03-12

决定日期2020-03-12

产品代码DIO

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决定实质等同

器械摘要

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Medtest DX. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K191638. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Medtest DX. The 510(k) number is K191638.

When did Pointe Scientific Cocaine Metabolite Enzyme Immunoassay receive FDA 510(k) clearance?

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay received FDA 510(k) clearance on 2020-03-12, under 510(k) number K191638.

Who is the listed applicant for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

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

What is the FDA product code for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

The FDA product code for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is DIO.

列明Medtest DX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。

K191296Pointe Scientific 肌酸激酶（CK）试剂套装

相关器械（代码：DIO）

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。

K213211Carolina Liquid Chemistries 可卡因和可卡因代谢物酶免疫测定 (COCM) 测试系统Carolina Liquid Chemistries Corp.K211973DRI 可卡因代谢物检测Microgenics Corporation K181499DRI 可卡因代谢物检测Microgenics Corporation K170293Emit II Plus 可卡因代谢物检测Siemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries 可卡因和可卡因代谢物测试系统 (COCM)Carolina Liquid Chemistries Corporation K162395MP DOA-10 面板测试杯，MP DOA-11 面板测试杯Mp Biomedicals, LLC

官方来源

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