510(k) Report

Devices descending from K981030

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040586Mesacup Test Mpo, Model 11053Rhigene, Inc.20040—
+1K013285Relisa Mpo-Anca Test System for Antibodies to Myeloperoxidase, Model # 7096-15Immuno Concepts, Inc.20010—