SporView Rapid Read Biological Indicator SteamPlus Test Pack— 510(k) K181434

Name: FDA 510(k) clearance K181434
Creator: U.S. Food and Drug Administration
Published: 2018-11-14

Substantially Equivalent

Crosstex/Spsmedical, A Division of Cantel Medical

FDA 510(k) clearance K181434 for SporView Rapid Read Biological Indicator SteamPlus Test Pack, Substantially Equivalent on 2018-11-14. Applicant: Crosstex/Spsmedical, A Division of Cantel Medical. Device class: 2.

Clearance details

Applicant: Crosstex/Spsmedical, A Division of Cantel Medical
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2018-06-01
Decision date: 2018-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rush, NY, US

Download summary PDF View on FDA.gov ↗

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