510(k) K061841

QUANTA LITE INTRINSIC FACTOR ELISA by Inova Diagnostics, Inc. — Product Code LIG

K061841 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE INTRINSIC FACTOR ELISA". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code LIG (Radioassay, Intrinsic Factor Blocking Antibody), a Class II device regulated under 21 CFR 862.1810. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.