Cleared Traditional

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

K182719 · Quidel Cardiovascular, Inc. · Toxicology
Jun 2019
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K182719 is an FDA 510(k) clearance for the Quidel Triage TOX Drug Screen, 94600; Quidel Triage? MeterPro, 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 June 19, 2019, 264 days after receiving the submission on September 28, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K182719 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2018
Decision Date June 19, 2019
Days to Decision 264 days
Submission Type Traditional
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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