510(k) K071346

IMMULISA INTRINSIC FACTOR ANTIBODY ELISA by Immco Diagnostics, Inc. — Product Code LIG

K071346 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA INTRINSIC FACTOR ANTIBODY ELISA". The FDA issued a decision of Substantially Equivalent on September 24, 2007. The device falls under product code LIG (Radioassay, Intrinsic Factor Blocking Antibody), a Class II device regulated under 21 CFR 862.1810. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.