Cleared Traditional

THERMO SCIENTIFIC MAS R DOA TOTAL

K103656 · Microgenics Corporation · Toxicology
Mar 2011
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K103656 is an FDA 510(k) clearance for the THERMO SCIENTIFIC MAS R DOA TOTAL, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on March 24, 2011, 99 days after receiving the submission on December 15, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K103656 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2010
Decision Date March 24, 2011
Days to Decision 99 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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