510(k) K233682

VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE by STERIS Corporation — Product Code OVY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2023
Date Received
November 16, 2023
Clearance Type
Special
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.