510(k) Report

Devices descending from K992502

2 later devices reach Axis %CDT Turbidimetric Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060677N Latex CDTDade Behring, Inc.200612
+2K110169Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con HSiemens Healthcare Diagnostics20110—