510(k) Report

Devices descending from K991709

6 later devices reach Browne Cidex Opa Indicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181472AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC MonitorAdvanced Sterilization Products (Asp)20190—
+1K081370Serim Disintek Opa Test StripSerim Research Corp.20082—
+1K081427Browne Opa Test StripSTERIS Corporation20082—
+2K241344MetriCide™ OPA Plus Solution Test StripSteris20240—
+2K202565WAVICIDE-OPA MEC IndicatorSerim Research Corporation20200—
+2K120652Rapicide Opa-28 Test StripSerim Research Corp.20120—