510(k) K822605

TOXOPLASMA GONDII ANTIBODY IGG by Immulok, Inc. — Product Code LJK

K822605 is an FDA 510(k) premarket notification submitted by Immulok, Inc. for the device "TOXOPLASMA GONDII ANTIBODY IGG". The FDA issued a decision of Substantially Equivalent on October 27, 1982. The device falls under product code LJK (Antisera, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Immulok, Inc. has at least 10 other 510(k) clearances on record.