510(k) K122599

ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR by Siemens Healthcare Diagnostics, Inc. — Product Code DDR

K122599 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on October 3, 2012. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.