Cleared Traditional

TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002

K014247 · Biosite Incorporated · Toxicology
Jun 2002
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K014247 is an FDA 510(k) clearance for the TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on June 3, 2002, 159 days after receiving the submission on December 26, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K014247 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2001
Decision Date June 03, 2002
Days to Decision 159 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

Similar Devices — DKZ Enzyme Immunoassay, Amphetamine

All 224
DRI Ecstasy Plus Assay
K240670 · Microgenics Corporation · Oct 2024
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
K233019 · Hangzhou AllTest Biotech Co., Ltd. · Dec 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137 · Xenta Biomedical Science Co., Ltd. · May 2023
Quidel Triage? TOX Drug Screen, 94600
K200363 · Quidel Cardiovascular, Inc. · Mar 2020
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099 · Atlas Medical · Oct 2019
Quidel Triage TOX Drug Screen, 94600; Quidel Triage? MeterPro
K182719 · Quidel Cardiovascular, Inc. · Jun 2019