510(k) Report

Devices descending from K031717

4 later devices reach Elecsys SHBG Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102814Elecysys SHBGRoche Diagnostics20110—
+1K060818Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control…Biokit, S.A.200721
+2K152185Architect SHBGBiokit, S.A.20160—
+2K143075ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetTosoh Bioscience, Inc.201501