510(k) K083260

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN by Roche Diagnostics — Product Code DDR

K083260 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN". The FDA issued a decision of Substantially Equivalent on October 16, 2009. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Roche Diagnostics has at least 10 other 510(k) clearances on record.