510(k) K092051

THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 by Microgenics Corp. — Product Code JJY

K092051 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158". The FDA issued a decision of Substantially Equivalent on September 21, 2009. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Microgenics Corp. has at least 10 other 510(k) clearances on record.