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510(k) K231746

VERIFY Spore Test Strip for S40 Sterilant Concentrate by STERIS Corporation — Product Code OVY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2023
Date Received
June 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liquid Chemical Processing System
Device Class
Class II
Regulation Number
880.6887
Review Panel
HO
Submission Type

The liquid chemical processing system is intended as a standard method for routine monitoring.

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Other clearances for product code OVY

  • K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE (December 15, 2023)
  • K180553 — VERIFY Spore Test Strip for S40 Sterilant (May 29, 2018)
  • DEN110002 — SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT (March 30, 2012)