510(k) K041192

ARCHITECT STAT TROPONIN-I IMMUNOASSAY by Fisher Diagnostics — Product Code MMI

K041192 is an FDA 510(k) premarket notification submitted by Fisher Diagnostics for the device "ARCHITECT STAT TROPONIN-I IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on August 12, 2004. 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.