510(k) K894946

PLATELIA RUBELLA IGG KIT by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code LFX

K894946 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "PLATELIA RUBELLA IGG KIT". The FDA issued a decision of Substantially Equivalent on December 21, 1989. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.