DeviceClearance

ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM— 510(k) K142133

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K142133 for ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM, Substantially Equivalent on 2014-10-24. Applicant: Roche Diagnostics.

Clearance details

Applicant
Roche Diagnostics
Product code
Code LFZ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.