Sofia RSV FIA on Sofia 2 analyzer— 510(k) K162911

Name: FDA 510(k) clearance K162911
Creator: U.S. Food and Drug Administration
Published: 2017-02-22

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K162911 for Sofia RSV FIA on Sofia 2 analyzer, Substantially Equivalent on 2017-02-22. Applicant: Quidel Corporation. Device class: 1.

Clearance details

Applicant: Quidel Corporation
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 2016-10-17
Decision date: 2017-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego,, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K162911

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 K162911.

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