Lyra RSV+hMPV Assay— 510(k) K230349

Substantially Equivalent

Quidel Corporation

FDA 510(k) clearance K230349 for Lyra RSV+hMPV Assay, Substantially Equivalent on 2023-03-10. Applicant: Quidel Corporation.

Clearance details

Applicant: Quidel Corporation
Product code: Code OEM
Advisory panel: Microbiology
Date received: 2023-02-09
Decision date: 2023-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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