510(k) Report

Devices descending from K955851

5 later devices reach Axsym Vancomycin II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072036Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25…Biokit, S.A.200811
+1K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp.20060—
+1K032811Cedia Vancomycin AssayMicrogenics Corp.20030—
+1K013076Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin CalibratorBeckman Coulter, Inc.200101
+2K123947Architect IvancomycinBiokit, S.A.20130—