Solana Strep Complete Assay— 510(k) K162274

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K162274 for Solana Strep Complete Assay, Substantially Equivalent on 2016-10-25. Applicant: Quidel Corporation.

Clearance details

Applicant: Quidel Corporation
Product code: Code PGX
Advisory panel: Microbiology
Date received: 2016-08-12
Decision date: 2016-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

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