510(k) K120936

ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS by Microgenics Corporation — Product Code DKB

K120936 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS". The FDA issued a decision of Substantially Equivalent on December 13, 2012. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Microgenics Corporation has at least 10 other 510(k) clearances on record.