ARCHITECT ROMA— 510(k) K151502

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K151502 for ARCHITECT ROMA, Substantially Equivalent on 2016-04-28. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code ONX
Advisory panel: Obstetrics/Gynecology
Date received: 2015-06-04
Decision date: 2016-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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