510(k) K811721

H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME by Immulok, Inc. — Product Code DFH

K811721 is an FDA 510(k) premarket notification submitted by Immulok, Inc. for the device "H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME". The FDA issued a decision of Substantially Equivalent on July 16, 1981. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Immulok, Inc. has at least 10 other 510(k) clearances on record.