FDA 510(k)

Psychemedics 同质化酶免疫测定用于检测头发中的安非他明

K号: K210212 · 2021-12-15

决定日期2021-12-15

产品代码LAF

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决定实质等同

器械摘要

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines 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 2021-12-15 under 510(k) number K210212. 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 Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair?

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Psychemedics Corporation. The 510(k) number is K210212.

When did Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair receive FDA 510(k) clearance?

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair received FDA 510(k) clearance on 2021-12-15, under 510(k) number K210212.

Who is the listed applicant for Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines 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 Homogeneous Enzyme Immunoassay for Amphetamines in Hair?

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is LAF.

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 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 K192517Psychemedics微孔板酶联免疫吸附测定法，用于检测头发中的尼古丁 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

查看所有 7 个设备 →

官方来源

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