510(k) Report

Devices descending from K171059

2 later devices reach Nova StatSensor Creatinine Hospital Meter System through their predicates, nearest generation first.

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