510(k) Report

Devices descending from K060345

19 later devices reach Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150281StatStrip Glucose Hospital MeterNova Biomedical Corporation20155—
+1K132121Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation201412—
+1K121679Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics201253
+2K200788Assure Titanium Blood Glucose Monitoring SystemArkray, Inc.20221—
+2K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation20184—
+2K150461StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation20153—
+2K133741ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics201431
+2K130138Super Sani-Cloth/ Accu-Chek Inform II SystemRoche Diagnostics Corp.20130—
+3K252323cobas pulse blood glucose monitoring systemRoche Diagnostics20260—
+3K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation20240—
+3K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation20240Class I
+3K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation20180—
+3K182549StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation20180—
+3K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose…Tyson Bioresearch, Inc.20172—
+3K161856StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation20160—
+3K152986StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation20161—
+4K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose…Tyson Bioresearch, Inc.20180—
+4K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose…Tyson Bioresearch, Inc.20180—
+4K163490StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation20170—