SOFIA ANALYZER AND INFLUENZA A+B FIA— 510(k) K112177

Name: FDA 510(k) clearance K112177
Creator: U.S. Food and Drug Administration
Published: 2011-10-24

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K112177 for SOFIA ANALYZER AND INFLUENZA A+B FIA, Substantially Equivalent on 2011-10-24. Applicant: Quidel Corp.. Device class: 2.

Clearance details

Applicant: Quidel Corp.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2011-07-28
Decision date: 2011-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K112177

K-number listed on FDA's recall record

Z-0819-2013 — Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.Class II·Terminated·Quidel Corporation·20121203

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112177.

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