Solana GBS Assay— 510(k) K173250

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K173250 for Solana GBS Assay, Substantially Equivalent on 2017-12-21. Applicant: Quidel Corporation.

Clearance details

Applicant: Quidel Corporation
Product code: Code NJR
Advisory panel: Microbiology
Date received: 2017-10-10
Decision date: 2017-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, OH, US

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