510(k) Report

Devices descending from K964264

3 later devices reach High Range Peroxide Test Strip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc.20162—
+2K251035DISINTEK™ PA Test StripsSerim Research20250—
+2K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation20250—