Cleared Traditional

QUEST TUMOR MARKER CONTROL, MODEL 955

K042815 · Bio-Rad · Immunology
Nov 2004
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K042815 is an FDA 510(k) clearance for the QUEST TUMOR MARKER CONTROL, MODEL 955, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on November 5, 2004, 24 days after receiving the submission on October 12, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K042815 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2004
Decision Date November 05, 2004
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
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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