510(k) Report

Devices descending from K981029

2 later devices reach Bindazyme Anti-PR3 Enzyme Immunoassay Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040711Mesacup Test PR-3Rhigene, Inc.20040—
+1K013283Relisa PR3-Anca Test System for Antibodies to Proteinase 3, Model # 7096-16Immuno Concepts, Inc.20010—