K220911

Substantially Equivalent

Elecsys CMV IgG

Applicant: Roche Diagnostics
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.