510(k) Report

Devices descending from K131703

3 later devices reach Nova Stat Profile Prime CCS Analyzer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141907Stat Profile Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat…Nova Biomedical Corporation201501
+1K142220Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)Nova Biomedical Corporation201411
+2K151982Stat Profile Prime ABG Analyzer SystemNova Biomedical Corporation201501