510(k) Report

Devices descending from K972035

9 later devices reach Sporox Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081600Steris Resert XL Test StripSTERIS Corporation20088—
+2K102296Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2)STERIS Corporation20111—
+2K102217System 1E Chemical IndicatorSTERIS Corporation20105—
+3K230558Revital-Ox PAA High Level Disinfectant Chemical IndicatorSTERIS Corporation20230—
+3K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation20183—
+3K143333Revital-Ox RESERT Solution Test StripSTERIS Corporation20150—
+4K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation20241—
+4K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant…Steris20230—
+5K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation20240—