510(k) Report

Devices descending from K042291

11 later devices reach Unicel DXC 600 and 800 Synchron Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20204—
+1K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20205—
+1K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20204—
+1K103842Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System…Beckman Coulter, Inc.201103
+1K071283Synchron Systems Creatinine ReagentBeckman Coulter, Inc.20070—
+1K060935Synchron Systems Creatinine (Crea) ReagentBeckman Coulter, Inc.20060—
+2K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+2K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20213—
+3K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20231—
+3K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+4K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps20260—