IMMUNOCARD STAT! FLU A & B— 510(k) K041626

Name: FDA 510(k) clearance K041626
Creator: U.S. Food and Drug Administration
Published: 2005-03-16

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K041626 for IMMUNOCARD STAT! FLU A & B, Substantially Equivalent on 2005-03-16. Applicant: Meridian Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Product code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2004-06-16
Decision date: 2005-03-16
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.