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

Name: FDA 510(k) clearance K162438
Creator: U.S. Food and Drug Administration
Published: 2017-04-14

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. 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: 2016-08-31
Decision date: 2017-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego,, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PSZ

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K254262 — Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA2026-09-04
K252283 — Nano-Check Influenza A+B Test2026-01-15
K250398 — Innovita Flu A/B Antigen Rapid Test2025-07-03
K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System2025-04-18
K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit2023-12-05

More clearances from Quidel Corporation

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Recalls naming K162438

K-number listed on FDA's recall record

Z-1183-2018 — Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.Class II·Terminated·Quidel Corporation·20171215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162438.

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