Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set— 510(k) K233688

Name: FDA 510(k) clearance K233688
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K233688 for Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set, Substantially Equivalent on 2023-12-13. Applicant: Quidel Corporation. Device class: 2.

Clearance details

Applicant: Quidel Corporation
Product code: Code QVF
Device class: Class 2
Regulation: 21 CFR 866.3982
Advisory panel: Microbiology
Date received: 2023-11-17
Decision date: 2023-12-13
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.