Cleared Traditional

LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK

K120504 · Bio-Rad Laboratories, Inc. · Chemistry
Mar 2012
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K120504 is an FDA 510(k) clearance for the LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK, 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 March 27, 2012, 35 days after receiving the submission on February 21, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K120504 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2012
Decision Date March 27, 2012
Days to Decision 35 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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