IMMUNOCARD STAT! E. COLI O157 PLUS— 510(k) K023599

Name: FDA 510(k) clearance K023599
Creator: U.S. Food and Drug Administration
Published: 2003-01-03

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K023599 for IMMUNOCARD STAT! E. COLI O157 PLUS, Substantially Equivalent on 2003-01-03. 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: 2002-10-28
Decision date: 2003-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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