SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT— 510(k) DEN110002

Name: FDA 510(k) clearance DEN110002
Creator: U.S. Food and Drug Administration
Published: 2012-03-30

Unknown

STERIS Corporation

FDA 510(k) clearance DEN110002 for SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT, Unknown on 2012-03-30. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code OVY
Device class: Class 2
Regulation: 21 CFR 880.6887
Advisory panel: General Hospital
Date received: 2011-08-01
Decision date: 2012-03-30
Decision: Unknown
Clearance type: Post-NSE
Location: Mentor, OH, US

View on FDA.gov ↗

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