510(k) K101752

THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS by Microgenics Corp. — Product Code DKB

K101752 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS". The FDA issued a decision of Substantially Equivalent on April 8, 2011. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Microgenics Corp. has at least 10 other 510(k) clearances on record.