510(k) K180553

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2018
Date Received
March 1, 2018
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.