LYRA PARAINFLUENZA VIRUS ASSAY— 510(k) K141927

Name: FDA 510(k) clearance K141927
Creator: U.S. Food and Drug Administration
Published: 2014-10-09

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K141927 for LYRA PARAINFLUENZA VIRUS ASSAY, Substantially Equivalent on 2014-10-09. Applicant: Quidel Corporation. Device class: 2.

Clearance details

Applicant: Quidel Corporation
Product code: Code OOU
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2014-07-16
Decision date: 2014-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

Download summary PDF View on FDA.gov ↗

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