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510(k) K232103

Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) by Terragene S.A. — Product Code QKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2024
Date Received
July 14, 2023
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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Other clearances for product code QKM

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  • K213262 — CELERITY HP Chemical Indicator (January 7, 2022)
  • K203284 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (December 7, 2020)
  • K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (March 13, 2020)