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510(k) DEN110002

SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT by STERIS Corporation — Product Code OVY

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 30, 2012
Date Received
August 1, 2011
Clearance Type
Post-NSE
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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