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510(k) K213262

CELERITY HP Chemical Indicator by STERIS Corporation — Product Code QKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2022
Date Received
September 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
A Chemical Vapor Sterilization Multivariable Chemical Indicator
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.

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