Cleared Traditional

THERMO SCIENTIFIC MAS OMNI-CORE

K110738 · Microgenics Corporation · Chemistry
Nov 2011
Decision
231d
Days
Class 1
Risk

About This 510(k) Submission

K110738 is an FDA 510(k) clearance for the THERMO SCIENTIFIC MAS OMNI-CORE, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on November 3, 2011, 231 days after receiving the submission on March 17, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K110738 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2011
Decision Date November 03, 2011
Days to Decision 231 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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