510(k) Report

Devices descending from K062467

5 later devices reach Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112443Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.20114—
+2K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.20240—
+2K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…Axis-Shield Diagnostics Limited20161—
+2K121946Axis-Shield Acvtive-B12Axis-Shield Diagnostics, Ltd.20130—
+3K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.20170—