Cleared Traditional

LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)

K042865 · Bio-Rad · Chemistry
Nov 2004
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K042865 is an FDA 510(k) clearance for the LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S), a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on November 24, 2004, 37 days after receiving the submission on October 18, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K042865 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2004
Decision Date November 24, 2004
Days to Decision 37 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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