510(k) Report

Devices descending from K103402

3 later devices reach Elecsys Dhea-S Calcheck 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112104Elecsys N-Mid Osteocalcin Calcheck 5Roche Diagnostics20110—
+1K110613Elecsys Prolactin II Calcheck 5Roche Diagnostics20111—
+2K143194ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve…Siemens Healthcare Diagnostics, Inc.20140—