TRU FLU— 510(k) K071657

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K071657 for TRU FLU, Substantially Equivalent on 2007-11-15. 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: 2007-06-18
Decision date: 2007-11-15
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.