K182467

Substantially Equivalent

Simplexa GBS Direct, Simplexa GBS Positive Control Pack

Applicant: Diasorin Molecular, LLC
Product code: NJR
Advisory panel: Microbiology
Date received: 2018-09-10
Decision date: 2018-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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