510(k) K181438

Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay by Diazyme Laboratories, Inc. — Product Code DFH

K181438 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories, Inc. for the device "Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay". The FDA issued a decision of Substantially Equivalent on June 26, 2018. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Diazyme Laboratories, Inc. has at least 10 other 510(k) clearances on record.