510(k) Report

Devices descending from K834502

8 later devices reach CK-Nac Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081731Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…Siemens Healthcare Diagnostics200831
+1K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—
+1K992140Piccolo Metlyte 7 Reagent DiscAbaxis, Inc.199912
+1K981218Creatine Kinase (CK)Abbott Laboratories19980—
+2K200865Piccolo Potassium Test SystemAbaxis, Inc.20210—
+2K083465Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine…Siemens Healthcare Diagnostics200901
+2K083579Dimension Vista System Enzyme 6 Calibrator, Model KC360Siemens Healthcare Diagnostics20091—
+3K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.201602