Cleared Traditional

LIQUICHEK ELEVATED CRP CONTROL

K042837 · Bio-Rad · Chemistry
Nov 2004
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K042837 is an FDA 510(k) clearance for the LIQUICHEK ELEVATED CRP CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on November 2, 2004, 19 days after receiving the submission on October 14, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K042837 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2004
Decision Date November 02, 2004
Days to Decision 19 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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