FDA 510(k)

Alinity c 三环类抗抑郁药试剂套件

K号: K231020 · 2023-11-17

决定日期2023-11-17

产品代码LFH

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决定实质等同

器械摘要

Alinity c Tricyclic Antidepressants Reagent Kit is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K231020. The device is classified under product code LFH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alinity c Tricyclic Antidepressants Reagent Kit?

Alinity c Tricyclic Antidepressants Reagent Kit is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Microgenics Corporation. The 510(k) number is K231020.

When did Alinity c Tricyclic Antidepressants Reagent Kit receive FDA 510(k) clearance?

Alinity c Tricyclic Antidepressants Reagent Kit received FDA 510(k) clearance on 2023-11-17, under 510(k) number K231020.

Who is the listed applicant for Alinity c Tricyclic Antidepressants Reagent Kit?

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

What is the FDA product code for Alinity c Tricyclic Antidepressants Reagent Kit?

The FDA product code for Alinity c Tricyclic Antidepressants Reagent Kit is LFH.

列明Microgenics 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。

K243498Alinity c 苯二氮卓类药物试剂套件 K240670DRI 摇滚药检测 K231007CEDIA 海洛因代谢物（6-AM）检测 K213875DRI TM 三环类血清毒物检测 K211973DRI 可卡因代谢物检测 K192943CEDIA 海洛因代谢物（6-AM）检测

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官方来源

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