ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT— 510(k) K112125

Name: FDA 510(k) clearance K112125
Creator: U.S. Food and Drug Administration
Published: 2011-12-05

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K112125 for ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT, Substantially Equivalent on 2011-12-05. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Product code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2011-07-25
Decision date: 2011-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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