FDA 510(k)

Quidel Triage® TOX Drug Screen, 94600

K-Number: K200363 · 2020-03-11

Decision Date2020-03-11

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Quidel Cardiovascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

Related Devices (Code: DKZ)

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.