510(k) Report

Devices descending from K860021

21 later devices reach Dimension (TM) Clinical Chemistry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090330Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine…Siemens Healthcare Diagnostics, Inc.200905
+1K083339Dimension RXL Max with Advia Modular Automation System (Amas)Siemens Healthcare Diagnostics, Inc.20090—
+1K061792Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex…Dade Behring, Inc.200602
+1K061818Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330)Dade Behring, Inc.200621
+1K061390Dimension Vista System ENZYME2 Calibrator, Model KC320Dade Behring, Inc.20063—
+1K061238Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent…Dade Behring, Inc.200611
+1K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…Dade Behring, Inc.200601
+1K051087Dimension Vista Integrated SystemDade Behring, Inc.2005532
+1K031135Glucose Flex Reagent Cartridge (Gluc)Dade Behring, Inc.20032—
+2K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics201505
+2K133728Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc.20140—
+2K122323Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista…Siemens Healthcare Diagnostics201201
+2K121907Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension Alkaline Phosphatase…Siemens Healthcare Diagnostics20120—
+2K103836Enzyme II CalibratorSiemens Healthcare Diagnostics, Inc.201102
+2K103612Dimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc.201111
+2K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081—
+2K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc.200613
+2K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.200617
+3K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc.20150—
+3K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics201502
+3K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—