CELERITY HP Chemical Indicator— 510(k) K213262

Name: FDA 510(k) clearance K213262
Creator: U.S. Food and Drug Administration
Published: 2022-01-07

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K213262 for CELERITY HP Chemical Indicator, Substantially Equivalent on 2022-01-07. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code QKM
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2021-09-30
Decision date: 2022-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.