TRU RSV— 510(k) K071101

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K071101 for TRU RSV, Substantially Equivalent on 2007-10-18. Applicant: Meridian Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code GOG
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 2007-04-19
Decision date: 2007-10-18
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.