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FDA 510(k)

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

K-Number: K182719 · 2019-06-19

ApplicantQuidel Cardiovascular, Inc.
Decision Date2019-06-19
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro is a medical device manufactured by Quidel Cardiovascular, Inc.. It received FDA 510(k) clearance on 2019-06-19 under approval number K182719. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Quidel Cardiovascular, Inc.. The 510(k) number is K182719.

When was Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro approved by the FDA?

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

What company makes Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro?

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro is manufactured by Quidel Cardiovascular, Inc..

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.

Other Devices by Quidel Cardiovascular, Inc.

K200363Quidel Triage® TOX Drug Screen, 94600

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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