Solana Trichomonas Assay— 510(k) K161182

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K161182 for Solana Trichomonas Assay, Substantially Equivalent on 2016-08-15. Applicant: Quidel Corporation.

Clearance details

Applicant: Quidel Corporation
Product code: Code OUY
Advisory panel: Immunology
Date received: 2016-04-27
Decision date: 2016-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

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