510(k) Report

Devices descending from K003178

2 later devices reach Elecsys HCG and Beta Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.20230—
+1K131037Liaison XL HCGDiaSorin, Inc.20130—