510(k) Report

Devices descending from K003329

2 later devices reach Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013544Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc.20010—
+1K013545Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc.20010—