Cleared Traditional

CARDIOIMMUNE XL CARDIAC MARKER CONTROL

K061196 · Microgenics Corp. · Chemistry
May 2006
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K061196 is an FDA 510(k) clearance for the CARDIOIMMUNE XL CARDIAC MARKER CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on May 30, 2006, 32 days after receiving the submission on April 28, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K061196 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2006
Decision Date May 30, 2006
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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