510(k) Report

Devices descending from K993571

7 later devices reach Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030655Holotc RiaAxis-Shield Biochemicals, Asa20046—
+2K062467Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01…Axis-Shield Diagnostics, Ltd.20065—
+3K112443Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.20114—
+4K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.20240—
+4K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…Axis-Shield Diagnostics Limited20161—
+4K121946Axis-Shield Acvtive-B12Axis-Shield Diagnostics, Ltd.20130—
+5K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.20170—