510(k) Report

Devices descending from K003267

1 later device reach Sigma Diagnostics Auto D-Dimer, Model CRS126-a through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013549Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971Sigma Diagnostics, Inc.20010—