SPOR-TEST PA BIOLOGICAL INDICATOR KIT— 510(k) K050664

Name: FDA 510(k) clearance K050664
Creator: U.S. Food and Drug Administration
Published: 2005-04-07

Substantially Equivalent

Getinge USA, Inc.

FDA 510(k) clearance K050664 for SPOR-TEST PA BIOLOGICAL INDICATOR KIT, Substantially Equivalent on 2005-04-07. Applicant: Getinge USA, Inc.. Device class: 2.

Clearance details

Applicant: Getinge USA, Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2005-03-15
Decision date: 2005-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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