510(k) K974839

ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT by First Medical, Inc. — Product Code MMI

K974839 is an FDA 510(k) premarket notification submitted by First Medical, Inc. for the device "ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT". The FDA issued a decision of Substantially Equivalent on February 4, 1998. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. First Medical, Inc. has at least 3 other 510(k) clearances on record.