510(k) Report

Devices descending from K170681

1 later device reach Continuous Single Culture -NX (CSCM-NX) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAKitazato Corporation20200—