510(k) Report

Devices descending from K070068

3 later devices reach Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171059Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical Corporation20172—
+2K261039i-STAT Crea cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20260—
+2K251281Nova Max Creat eGFR Monitoring SystemNova Biomedical Corporation20260—