Cleared Traditional

TRIAGE TOX DRUG SCREEN, MODEL 94400

K060791 · Biosite Incorporated · Toxicology
Jun 2006
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K060791 is an FDA 510(k) clearance for the TRIAGE TOX DRUG SCREEN, MODEL 94400, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Biosite Incorporated (San Deigo, US). The FDA issued a Cleared decision on June 22, 2006, 91 days after receiving the submission on March 23, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K060791 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2006
Decision Date June 22, 2006
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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