Elecsys CMV IgG— 510(k) K220911

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K220911 for Elecsys CMV IgG, Substantially Equivalent on 2022-10-12. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LFZ
Advisory panel: Microbiology
Date received: 2022-03-29
Decision date: 2022-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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