FDA 510(k)

Quidel Triage® TOX 药物筛查，94600

K号: K200363 · 2020-03-11

决定日期2020-03-11

产品代码DKZ

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决定实质等同

器械摘要

Quidel Triage® TOX Drug Screen, 94600 is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Cardiovascular, Inc.. It received FDA 510(k) clearance on 2020-03-11 under 510(k) number K200363. 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 Quidel Triage® TOX Drug Screen, 94600?

Quidel Triage® TOX Drug Screen, 94600 is a medical device that received FDA 510(k) clearance on 2020-03-11. The listed applicant is Quidel Cardiovascular, Inc.. The 510(k) number is K200363.

When did Quidel Triage® TOX Drug Screen, 94600 receive FDA 510(k) clearance?

Quidel Triage® TOX Drug Screen, 94600 received FDA 510(k) clearance on 2020-03-11, under 510(k) number K200363.

Who is the listed applicant for Quidel Triage® TOX Drug Screen, 94600?

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

What is the FDA product code for Quidel Triage® TOX Drug Screen, 94600?

The FDA product code for Quidel Triage® TOX Drug Screen, 94600 is DKZ.

列明Quidel Cardiovascular, Inc.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。

K182719Quidel Triage TOX 药物筛查，94600；Quidel Triage® MeterPro

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.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.K182738单药和多药快速检测板（尿液），单药和多药快速检测板（尿液），单药和多药快速检测杯（尿液），单药和多药快速检测杯（尿液），单药快速检测试纸条（尿液），单药和多药家庭快速检测板（尿液），单药和多药家庭快速检测杯（尿液），单药家庭快速检测试纸条（尿液）Hangzhou AllTest Biotech Co., Ltd.

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