NAMSA BIOLOGICAL INDICATOR SPORE STRIPS— 510(k) K113221

Name: FDA 510(k) clearance K113221
Creator: U.S. Food and Drug Administration
Published: 2012-04-27

Substantially Equivalent

North American Science Assoc., Inc.

FDA 510(k) clearance K113221 for NAMSA BIOLOGICAL INDICATOR SPORE STRIPS, Substantially Equivalent on 2012-04-27. Applicant: North American Science Assoc., Inc.. Device class: 2.

Clearance details

Applicant: North American Science Assoc., Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2011-11-01
Decision date: 2012-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

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