510(k) Report

Devices descending from K883181

20 later devices reach Synchron CX4/CX5 Clinical Chemistry Analyzer Reage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131189Unicel DXC Synchron Systems Glucose Reagent (Gluh)Beckman Coulter, Inc.20140—
+1K041643Synchron Systems Phosphorus (PHS) ReagentBeckman Coulter, Inc.20040—
+1K965240Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX…Beckman Instruments, Inc.19971712
+2K071277Synchron LX20 Clinical Systems, Creatinine Test SystemsBeckman Coulter, Inc.200701
+2K042291Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc.20041134
+2K014034Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro)Beckman Coulter, Inc.200114
+2K971505Synchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc.199701
+2K970905Synchron CX Systems Lipase (Lipa) ReagentBeckman Instruments, Inc.199701
+3K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20204—
+3K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20205—
+3K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20204—
+3K103842Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System…Beckman Coulter, Inc.201103
+3K071283Synchron Systems Creatinine ReagentBeckman Coulter, Inc.20070—
+3K060935Synchron Systems Creatinine (Crea) ReagentBeckman Coulter, Inc.20060—
+3K040975Genchem CO2 Acid ReagentGenchem, Inc.20040—
+4K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+4K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20213—
+5K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20231—
+5K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+6K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps20260—