FDA 510(k)

CEDIA 苯二氮卓类药物检测

K号: K190968 · 2019-12-09

决定日期2019-12-09

产品代码JXM

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决定实质等同

器械摘要

CEDIA Benzodiazepine Assay is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K190968. 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 CEDIA Benzodiazepine Assay?

CEDIA Benzodiazepine Assay is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Microgenics Corporation. The 510(k) number is K190968.

When did CEDIA Benzodiazepine Assay receive FDA 510(k) clearance?

CEDIA Benzodiazepine Assay received FDA 510(k) clearance on 2019-12-09, under 510(k) number K190968.

Who is the listed applicant for CEDIA Benzodiazepine Assay?

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 CEDIA Benzodiazepine Assay?

The FDA product code for CEDIA Benzodiazepine Assay 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。

K243498Alinity c 苯二氮卓类药物试剂套件 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

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。

K243498Alinity c 苯二氮卓类药物试剂套件Microgenics Corporation K221765ONLINE DAT 苯二氮卓类药物 IIRoche Diagnostics 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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