Cleared Traditional

THERMO SCIENTIFIC MAS OMNI-CARDIO

K122291 · Microgenics Corporation · Chemistry
Aug 2012
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K122291 is an FDA 510(k) clearance for the THERMO SCIENTIFIC MAS OMNI-CARDIO, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on August 31, 2012, 31 days after receiving the submission on July 31, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K122291 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2012
Decision Date August 31, 2012
Days to Decision 31 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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