Elecsys CMV IgM— 510(k) K163569

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K163569 for Elecsys CMV IgM, Substantially Equivalent on 2017-03-17. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LFZ
Advisory panel: Microbiology
Date received: 2016-12-19
Decision date: 2017-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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