AmpliVue Bordetella Assay— 510(k) K143206

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K143206 for AmpliVue Bordetella Assay, Substantially Equivalent on 2014-12-10. Applicant: Quidel Corporation.

Clearance details

Applicant: Quidel Corporation
Product code: Code OZZ
Advisory panel: Microbiology
Date received: 2014-11-07
Decision date: 2014-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

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