FDA 510(k)

ACCU NEWS 药物筛查测试卡/尿液杯

K号: K152590 · 2016-04-15

决定日期2016-04-15

产品代码DKZ

咨询委员会TX 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

ACCU NEWS Drug Screening Test Card/Urine Cup is the device name listed in this FDA 510(k) record. The listed applicant is Coretests, Inc.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K152590. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ACCU NEWS Drug Screening Test Card/Urine Cup?

ACCU NEWS Drug Screening Test Card/Urine Cup is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Coretests, Inc.. The 510(k) number is K152590.

When did ACCU NEWS Drug Screening Test Card/Urine Cup receive FDA 510(k) clearance?

ACCU NEWS Drug Screening Test Card/Urine Cup received FDA 510(k) clearance on 2016-04-15, under 510(k) number K152590.

Who is the listed applicant for ACCU NEWS Drug Screening Test Card/Urine Cup?

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

What is the FDA product code for ACCU NEWS Drug Screening Test Card/Urine Cup?

The FDA product code for ACCU NEWS Drug Screening Test Card/Urine Cup is DKZ.

相关器械（代码：DKZ）

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Microgenics Corporation K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta药物筛查杯，Xenta药物筛查滴卡Xenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX 药物筛查，94600Quidel Cardiovascular, Inc.K191099Atlas 多药物筛查测试杯，Atlas 多药物筛查测试板Atlas Medical K182719Quidel Triage TOX 药物筛查，94600；Quidel Triage® MeterProQuidel Cardiovascular, Inc.

官方来源

在 FDA 数据库中查看 →

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。

器械摘要

常见问题

相关临床试验

相关器械（代码：DKZ）

官方来源