Cleared Traditional

LIQUID ASSAYED MULTIQUAL CONTROL

K043208 · Bio-Rad · Chemistry
Jan 2005
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K043208 is an FDA 510(k) clearance for the LIQUID ASSAYED MULTIQUAL CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bio-Rad (Ivrvine, US). The FDA issued a Cleared decision on January 7, 2005, 49 days after receiving the submission on November 19, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K043208 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2004
Decision Date January 07, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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