Cleared Traditional

TRIAGE TOX DRUG SCREEN CONTROLS

K050037 · Biosite Incorporated · Chemistry
Mar 2005
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K050037 is an FDA 510(k) clearance for the TRIAGE TOX DRUG SCREEN CONTROLS, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on March 22, 2005, 74 days after receiving the submission on January 7, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K050037 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2005
Decision Date March 22, 2005
Days to Decision 74 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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