FDA 510(k)

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

K号: K182719 · 2019-06-19

决定日期2019-06-19

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; Quidel Triage® MeterPro 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 2019-06-19 under 510(k) number K182719. 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® MeterPro?

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Quidel Cardiovascular, Inc.. The 510(k) number is K182719.

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

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182719.

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

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; Quidel Triage® MeterPro?

The FDA product code for Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro 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。

K200363Quidel Triage® TOX 药物筛查，94600

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。

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