K173498

Substantially Equivalent

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

Applicant: Diasorin Molecular, LLC
Product code: OZZ
Advisory panel: Microbiology
Date received: 2017-11-13
Decision date: 2018-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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