QUIDEL MOLECULAR INFLUENZA A + B ASSAY— 510(k) K131728

Name: FDA 510(k) clearance K131728
Creator: U.S. Food and Drug Administration
Published: 2013-08-29

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K131728 for QUIDEL MOLECULAR INFLUENZA A + B ASSAY, Substantially Equivalent on 2013-08-29. Applicant: Quidel Corp.. Device class: 2.

Clearance details

Applicant: Quidel Corp.
Product code: Code OZE
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2013-06-12
Decision date: 2013-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
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.