Cleared Traditional

TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414

K060788 · Biosite Incorporated · Chemistry
Jul 2006
Decision
109d
Days
Class 1
Risk

About This 510(k) Submission

K060788 is an FDA 510(k) clearance for the TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Biosite Incorporated (San Deigo, US). The FDA issued a Cleared decision on July 10, 2006, 109 days after receiving the submission on March 23, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K060788 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2006
Decision Date July 10, 2006
Days to Decision 109 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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