510(k) Report

Devices descending from K182098

2 later devices reach N Latex FLC kappa assay, N Latex FLC lambda assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212379N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH20220—
+1K190879N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH20190—