IMMUNOCARD STAT! RSV MODEL #750630— 510(k) K041445

Name: FDA 510(k) clearance K041445
Creator: U.S. Food and Drug Administration
Published: 2004-08-13

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K041445 for IMMUNOCARD STAT! RSV MODEL #750630, Substantially Equivalent on 2004-08-13. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 2004-06-01
Decision date: 2004-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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