Cleared Traditional

LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)

K050682 · Bio-Rad Laboratories, Inc. · Toxicology
Apr 2005
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K050682 is an FDA 510(k) clearance for the LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1), a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Bio-Rad Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on April 29, 2005, 44 days after receiving the submission on March 16, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K050682 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2005
Decision Date April 29, 2005
Days to Decision 44 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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