Cleared Traditional

LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)

K033404 · Bio-Rad · Toxicology
Dec 2003
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K033404 is an FDA 510(k) clearance for the LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES), a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Bio-Rad (Ivrvine, US). The FDA issued a Cleared decision on December 12, 2003, 49 days after receiving the submission on October 24, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K033404 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2003
Decision Date December 12, 2003
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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