Cleared Special

Quidel Triage? TOX Drug Screen, 94600

K200363 · Quidel Cardiovascular, Inc. · Toxicology
Mar 2020
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K200363 is an FDA 510(k) clearance for the Quidel Triage? TOX Drug Screen, 94600, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Quidel Cardiovascular, Inc. (San Deigo, US). The FDA issued a Cleared decision on March 11, 2020, 26 days after receiving the submission on February 14, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K200363 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2020
Decision Date March 11, 2020
Days to Decision 26 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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