
Diazyme Laboratories, Inc.
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Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay is an FDA 510(k)-cleared medical device (K211648) 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 September 7, 2022. Regulation: 8.