510(k) Report

Devices descending from K891093

11 later devices reach Aca (R) Digitoxin Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990255Dimension Drug Calibrator II, Model DC49BDade Behring, Inc.199910—
+2K032574Dimension Drug Calibrator II, Model DC49CDade Behring, Inc.20039—
+3K033809Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…Dade Behring, Inc.20048—
+4K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc.20162—
+4K103360Dimension Vista Digitoxin Calibrator - DGTX CalSiemens Corp.20100—
+4K090900Advia Chemistry Drug Calibrator II, Model 10376771Siemens Healthcare Diagnostics20090—
+4K062121Dimension Vista System Drug 2 Calibrator (Drug 2 Cal - KC420)Dade Behring, Inc.20060—
+4K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.200617
+5K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc.20230—
+5K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics201708
+5K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics201502