PREMIER CAMPY, MODEL 618096— 510(k) K083464

Name: FDA 510(k) clearance K083464
Creator: U.S. Food and Drug Administration
Published: 2009-01-30

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K083464 for PREMIER CAMPY, MODEL 618096, Substantially Equivalent on 2009-01-30. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code LQP
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2008-11-24
Decision date: 2009-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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