510(k) K894948

PLATELIA TOXO IGM KIT by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code LGD

K894948 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "PLATELIA TOXO IGM KIT". The FDA issued a decision of Substantially Equivalent on March 15, 1990. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.