510(k) Report

Devices descending from K990346

8 later devices reach Bayer Advia 1650 Chemistry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162020VITROS Chemistry Products Cl- SlidesOrtho Clinical Diagnostics201622
+1K151767Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A…Siemens Healthcare Diagnostics, Inc.2015312
+1K031924Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator…Ortho-Clinical Diagnostics2003029
+2K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.20230—
+2K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…Siemens Healthcare Diagnostics, Inc.202301
+2K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS…Ortho-Clinical Diagnostics, Inc.201812
+2K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics201708
+3K190520VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc.20190—