Cleared Traditional

LIQUICHEK WHOLE BLOOD VOLATILES CONTROL

K041561 · Bio-Rad · Chemistry
Jul 2004
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K041561 is an FDA 510(k) clearance for the LIQUICHEK WHOLE BLOOD VOLATILES CONTROL, 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 July 6, 2004, 26 days after receiving the submission on June 10, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K041561 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2004
Decision Date July 06, 2004
Days to Decision 26 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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