510(k) Report

Devices descending from K162606

1 later device reach Elecsys TSH assay, cobas e 801 Immunoassay analyzer through their predicates, nearest generation first.

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