Diazyme Laboratories, Inc. Announces FDA 501(k) Clearance for MGUS for Kappa and Lambda Free Light Chain Assays
14th Jan 2026
SAN DIEGO, CA - January 14, 2026 - Diazyme Laboratories, Inc. announces receiving 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the evaluation of monoclonal gammopathy of undetermined significance (MGUS) for Diazyme’s Kappa and Lambda Free Light Chain Assays.
“FDA 510(k) clearance of added indication to our free light chain kappa and lambda assays demonstra
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