FDA 510(k)

Alinity c 苯二氮卓类药物试剂套件

K号: K243498 · 2024-12-11

决定日期2024-12-11

产品代码JXM

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决定实质等同

器械摘要

Alinity c Benzodiazepines 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 2024-12-11 under 510(k) number K243498. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alinity c Benzodiazepines Reagent Kit?

Alinity c Benzodiazepines Reagent Kit is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Microgenics Corporation. The 510(k) number is K243498.

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

Alinity c Benzodiazepines Reagent Kit received FDA 510(k) clearance on 2024-12-11, under 510(k) number K243498.

Who is the listed applicant for Alinity c Benzodiazepines 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 Benzodiazepines Reagent Kit?

The FDA product code for Alinity c Benzodiazepines Reagent Kit is JXM.

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。

K240670DRI 摇滚药检测 K231020Alinity c 三环类抗抑郁药试剂套件 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

查看所有 13 个设备 →

相关器械（代码：JXM）

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。

K221765ONLINE DAT 苯二氮卓类药物 IIRoche Diagnostics K190968CEDIA 苯二氮卓类药物检测Microgenics Corporation K173963DRI 苯二氮卓类药物检测Microgenics Corporation 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Psychemedics Corporation K163704Healgen 多药物尿液测试杯；Healgen 多药物尿液测试条Healgen Scientific,, LLC K153597Healgen 多药物尿液测试杯，Healgen 多药物尿液测试条Healgen Scientific,, LLC

官方来源

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