Cleared Traditional

LIQUICHEK BNP CONTROL

K043584 · Bio-Rad Laboratories, Inc. · Chemistry
Feb 2005
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K043584 is an FDA 510(k) clearance for the LIQUICHEK BNP CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Bio-Rad Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on February 8, 2005, 42 days after receiving the submission on December 28, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K043584 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2004
Decision Date February 08, 2005
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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