510(k) K812821

H-103 IGG, H-104 IGA, H-105 IGM by Immulok, Inc. — Product Code DFZ

K812821 is an FDA 510(k) premarket notification submitted by Immulok, Inc. for the device "H-103 IGG, H-104 IGA, H-105 IGM". The FDA issued a decision of Substantially Equivalent on October 26, 1981. The device falls under product code DFZ (Igg (Gamma Chain Specific), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Immulok, Inc. has at least 10 other 510(k) clearances on record.