Cleared Traditional

THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO

K110616 · Microgenics Corp. · Chemistry
Jun 2011
Decision
118d
Days
Class 1
Risk

About This 510(k) Submission

K110616 is an FDA 510(k) clearance for the THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO, 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 June 29, 2011, 118 days after receiving the submission on March 3, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K110616 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2011
Decision Date June 29, 2011
Days to Decision 118 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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