510(k) K173798— Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

Substantially Equivalent

Diasorin Molecular, LLC

Clearance details

Applicant: Diasorin Molecular, LLC
Product code: Code PGI
Advisory panel: Microbiology
Date received: 2017-12-14
Decision date: 2018-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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