510(k) K103656

THERMO SCIENTIFIC MAS R DOA TOTAL by Microgenics Corporation — Product Code DIF

K103656 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "THERMO SCIENTIFIC MAS R DOA TOTAL". The FDA issued a decision of Substantially Equivalent on March 24, 2011. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Microgenics Corporation has at least 10 other 510(k) clearances on record.