Cleared Traditional

QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL

K050536 · Bio-Rad · Chemistry
Mar 2005
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K050536 is an FDA 510(k) clearance for the QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL, 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 March 24, 2005, 22 days after receiving the submission on March 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K050536 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2005
Decision Date March 24, 2005
Days to Decision 22 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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