
Diazyme Laboratories, Inc.
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Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay is an FDA 510(k)-cleared medical device (K253358) manufactured by Diazyme Laboratories, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2025. Regulation: 8.