510(k) Report

Devices descending from K965240

17 later devices reach Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071277Synchron LX20 Clinical Systems, Creatinine Test SystemsBeckman Coulter, Inc.200701
+1K042291Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc.20041134
+1K014034Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro)Beckman Coulter, Inc.200114
+1K971505Synchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc.199701
+1K970905Synchron CX Systems Lipase (Lipa) ReagentBeckman Instruments, Inc.199701
+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—
+2K040975Genchem CO2 Acid ReagentGenchem, Inc.20040—
+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—