510(k) K974325

CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN by Chiron Diagnostics Corp. — Product Code DDR

K974325 is an FDA 510(k) premarket notification submitted by Chiron Diagnostics Corp. for the device "CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN". The FDA issued a decision of Substantially Equivalent on December 8, 1997. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Chiron Diagnostics Corp. has at least 10 other 510(k) clearances on record.