510(k) Report

Devices descending from DEN180040

1 later device reach Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackDiasorin Molecular, LLC20220—