510(k) K252336

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay by Diazyme Laboratories, Inc.

K252336 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories, Inc. for the device "Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay". The FDA issued a decision of Substantially Equivalent on April 24, 2026. Diazyme Laboratories, Inc. has at least 10 other 510(k) clearances on record.