510(k) Report

Devices descending from K011213

20 later devices reach Modification to Synchron LX 20 Clinical Chemistry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051108Piccolo Lactate Dephydrogenase Test SystemAbaxis, Inc.20050—
+1K042291Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc.20041134
+1K040174Bilirubin Assay on the Omni S AnalyzerRoche Diagnostics Corp.20040—
+1K023049Synchron LX I 725 Clinical SystemBeckman Coulter, Inc.2002418
+1K014034Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro)Beckman Coulter, Inc.200114
+2K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20204—
+2K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20205—
+2K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20204—
+2K103842Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System…Beckman Coulter, Inc.201103
+2K071283Synchron Systems Creatinine ReagentBeckman Coulter, Inc.20070—
+2K060935Synchron Systems Creatinine (Crea) ReagentBeckman Coulter, Inc.20060—
+2K060256Unicel DXC 600I Synchron Access Clinical SystemBeckman Coulter, Inc.2006124
+2K040975Genchem CO2 Acid ReagentGenchem, Inc.20040—
+2K042191Diazyme Potassium Enzymatic Assay KitDiazyme Laboratories20040—
+2K042189Diazyme Sodium Enzymatic AssayDiazyme Laboratories20040—
+3K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+3K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20213—
+4K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20231—
+4K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+5K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps20260—