QuickVue Influenza A+B— 510(k) K180288

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K180288 for QuickVue Influenza A+B, Substantially Equivalent on 2018-02-13. Applicant: Quidel Corporation. Device class: 2.

Clearance details

Applicant: Quidel Corporation
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2018-02-01
Decision date: 2018-02-13
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.