510(k) K042982

QUANTEX MYOGLOBIN by Instrumentation Laboratory CO — Product Code DDR

K042982 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "QUANTEX MYOGLOBIN". The FDA issued a decision of Substantially Equivalent on December 22, 2004. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.