510(k) Report

Devices descending from K211648

1 later device reach Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…Diazyme Laboratories, Inc.20250—