K142133

Substantially Equivalent

ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM

Applicant: Roche Diagnostics
Product code: LFZ
Advisory panel: Microbiology
Date received: 2014-08-04
Decision date: 2014-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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