510(k) Report

Devices descending from K855101

3 later devices reach Assert TM Biological/Chemical Indicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091950Smart-Well Eztest IncubatorSgm Biotech, Inc.20100—
+1K083665Verify Scbi 275F 3-10STERIS Corporation200907
+1K051056Verify Self-Contained Biological IndicatorAlbert Browne, Ltd.20051—