510(k) Report

Devices descending from K083868

1 later device reach Architect Anti-CCP (100 Test), Architect Anti-CCP (500 Test), Models 1P65-25… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153551ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality…Axis-Shield Diagnostics Limited201601