510(k) Report

Devices descending from K181043

4 later devices reach StatStrip Glucose Hospital Meter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252323cobas pulse blood glucose monitoring systemRoche Diagnostics20260—
+1K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation20240Class I
+1K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation20180—
+1K182549StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation20180—