510(k) K192376— Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

Substantially Equivalent

Diasorin Molecular, LLC

Clearance details

Applicant: Diasorin Molecular, LLC
Product code: Code PGI
Advisory panel: Microbiology
Date received: 2019-08-30
Decision date: 2019-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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