510(k) Report

Devices descending from K003158

9 later devices reach Roche Diagnostics CK-MB through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162526Creatine Kinase-MBRoche Diagnostics20170—
+1K123977Randox Liquid CK-MB, Randox CK-MB CalibratorRandox Laboratories, Ltd.20130—
+1K102706CKMB Udr AssaySENTINEL CH. SpA20110—
+1K101456Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator…Roche Diagnostics20100—
+1K081731Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…Siemens Healthcare Diagnostics200831
+1K062972Precinorm CK-MB and Precipath CK-MB ControlsRoche Diagnostics Corp.20060—
+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