Cleared Traditional

TRIAGE TOX DRUG SCREEN

K043242 · Biosite Incorporated · Toxicology
Feb 2005
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K043242 is an FDA 510(k) clearance for the TRIAGE TOX DRUG SCREEN, a Colorimetry, Acetaminophen (Class II — Special Controls, product code LDP), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on February 28, 2005, 97 days after receiving the submission on November 23, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3030.

Submission Details

510(k) Number K043242 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2004
Decision Date February 28, 2005
Days to Decision 97 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDP — Colorimetry, Acetaminophen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3030

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