ROMA Calculation Tool Using Elecsys Assays— 510(k) K153607

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K153607 for ROMA Calculation Tool Using Elecsys Assays, Substantially Equivalent on 2016-06-15. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code ONX
Advisory panel: Obstetrics/Gynecology
Date received: 2015-12-17
Decision date: 2016-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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