IMMUNOCARD STAT! EHEC, MODEL 751630— 510(k) K062546

Name: FDA 510(k) clearance K062546
Creator: U.S. Food and Drug Administration
Published: 2007-02-14

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K062546 for IMMUNOCARD STAT! EHEC, MODEL 751630, Substantially Equivalent on 2007-02-14. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 2006-08-30
Decision date: 2007-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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