FDA 510(k)

Psychemedics微孔板酶联免疫吸附测定法，用于检测头发中的尼古丁

K号: K192517 · 2020-04-22

决定日期2020-04-22

产品代码MKU

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决定实质等同

器械摘要

Psychemedics Microplate EIA for Cotinine in Hair is the device name listed in this FDA 510(k) record. The listed applicant is Psychemedics Corporation. It received FDA 510(k) clearance on 2020-04-22 under 510(k) number K192517. The device is classified under product code MKU. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Psychemedics Microplate EIA for Cotinine in Hair?

Psychemedics Microplate EIA for Cotinine in Hair is a medical device that received FDA 510(k) clearance on 2020-04-22. The listed applicant is Psychemedics Corporation. The 510(k) number is K192517.

When did Psychemedics Microplate EIA for Cotinine in Hair receive FDA 510(k) clearance?

Psychemedics Microplate EIA for Cotinine in Hair received FDA 510(k) clearance on 2020-04-22, under 510(k) number K192517.

Who is the listed applicant for Psychemedics Microplate EIA for Cotinine in Hair?

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

What is the FDA product code for Psychemedics Microplate EIA for Cotinine in Hair?

The FDA product code for Psychemedics Microplate EIA for Cotinine in Hair is MKU.

列明Psychemedics 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。

K212952Psychemedics 同质化酶免疫测定 (HEIA) 用于检测头发中的苯环己哌啶 K210212Psychemedics 同质化酶免疫测定用于检测头发中的安非他明 K201326Psychemedics 同质化酶免疫测定 (HEIA) 用于检测头发中的阿片类药物，Psychemedics 同质化酶免疫测定 (HEIA) 用于检测头发中的氧可酮 K201228Psychemedics同质化酶免疫测定法，用于检测头发中的可卡因 K182103Psychemedics微孔板酶联免疫吸附测定法，用于检测头发中的芬太尼 K163590Psychemedics微孔板酶联免疫吸附测定法，用于检测头发中的苯二氮卓类药物

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。