510(k) Report

Devices descending from K083867

2 later devices reach Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233480Access SHBGBeckman Coulter, Inc.20240—
+1K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen, Inc.201902