Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label— 510(k) K192020

Name: FDA 510(k) clearance K192020
Creator: U.S. Food and Drug Administration
Published: 2019-09-05

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K192020 for Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label, Substantially Equivalent on 2019-09-05. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2019-07-29
Decision date: 2019-09-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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