Sofia Influenza A+B FIA— 510(k) K153012

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K153012 for Sofia Influenza A+B FIA, Substantially Equivalent on 2016-01-12. Applicant: Quidel Corporation. Device class: 2.

Clearance details

Applicant: Quidel Corporation
Product code: Product code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2015-10-14
Decision date: 2016-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
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.