STREPTOCOCCUS APP. SEROLOGICAL REAGENTS— 510(k) K122019

Name: FDA 510(k) clearance K122019
Creator: U.S. Food and Drug Administration
Published: 2012-09-13

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K122019 for STREPTOCOCCUS APP. SEROLOGICAL REAGENTS, Substantially Equivalent on 2012-09-13. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code OYZ
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2012-07-10
Decision date: 2012-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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