510(k) Report

Devices descending from K060818

2 later devices reach Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152185Architect SHBGBiokit, S.A.20160—
+1K143075ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetTosoh Bioscience, Inc.201501