510(k) K070640

ARCHITECT STAT TROPONIN-1; MYOGLOBIN by Fisher Diagnostics — Product Code MMI

K070640 is an FDA 510(k) premarket notification submitted by Fisher Diagnostics for the device "ARCHITECT STAT TROPONIN-1; MYOGLOBIN". The FDA issued a decision of Substantially Equivalent on September 13, 2007. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Fisher Diagnostics has at least 10 other 510(k) clearances on record.