510(k) Report

Devices descending from K031016

8 later devices reach Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2Sebia20240—
+1K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2Sebia20220—
+1K201496N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH20211—
+1K193047N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH20211—
+1K182098N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH20182—
+1K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1…Siemens Healthcare Diagnostics Products GmbH20172—
+2K212379N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH20220—
+2K190879N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH20190—