CELERITY HP Chemical Indicator

A Chemical Vapor Sterilization Multivariable Chemical Indicator

Steris Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Celerity Hp Chemical Indicator.

Pre-market Notification Details

Device IDK213262
510k NumberK213262
Device Name:CELERITY HP Chemical Indicator
ClassificationA Chemical Vapor Sterilization Multivariable Chemical Indicator
Applicant Steris Corporation 5960 Heisley Rd Mentor,  OH  44060
ContactAnthony Piotrkowski
CorrespondentAnthony Piotrkowski
Steris Corporation 5960 Heisley Rd Mentor,  OH  44060
Product CodeQKM  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-01-07

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