DeviceClearance

Sofia Influenza A+B FIA on Sofia 2— 510(k) K162438

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K162438 for Sofia Influenza A+B FIA on Sofia 2, Substantially Equivalent on 2017-04-14. Applicant: Quidel Corporation.

Clearance details

Applicant
Quidel Corporation
Product code
Code PSZ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego,, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.