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510(k) K213262

Device
CELERITY HP Chemical Indicator
Applicant
Steris Corporation
510(k) number
K213262
Product code
QKM  
Decision
Substantially Equivalent (SESE)
Decision date
2022-01-07
Date received
2021-09-30
Regulation
880.2800
Classification name
A Chemical Vapor Sterilization Multivariable Chemical Indicator
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anthony Piotrkowski
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QKM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232103Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)Terragene S.A.2024-04-05
K2120223M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Company2022-04-20
K2032843M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company2020-12-07
K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Healthcare2020-03-13

Legacy Summary#

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FDA Review#

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