510(k) Report

Devices descending from K935806

2 later devices reach Immulite Dhea-S04 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040181Access Dhea-S Reagent AssayBeckman Coulter, Inc.20041—
+2K111762ST Aia-Pack Dhea-S Calibrator SetTosoh Bioscience, Inc.20110—