510(k) K182467— Simplexa GBS Direct, Simplexa GBS Positive Control Pack

Substantially Equivalent

Diasorin Molecular, LLC

Clearance details

Applicant: Diasorin Molecular, LLC
Product code: 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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