510(k) Report

Devices descending from K150281

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation20184—
+2K252323cobas pulse blood glucose monitoring systemRoche Diagnostics20260—
+2K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation20240Class I
+2K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation20180—
+2K182549StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation20180—