510(k) Report

Devices descending from K981330

2 later devices reach Quanta Lite Mpo Igg (Myeloperoxidase) Test Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140225Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/GBM…Phadia US, Inc.201411
+2K173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia AB201801