510(k) K984145

OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT by Olympus Diagnostica GmbH — Product Code DDR

K984145 is an FDA 510(k) premarket notification submitted by Olympus Diagnostica GmbH for the device "OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT". The FDA issued a decision of Substantially Equivalent on December 23, 1998. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Olympus Diagnostica GmbH has at least 3 other 510(k) clearances on record.