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

Name: FDA 510(k) clearance K142133
Creator: U.S. Food and Drug Administration
Published: 2014-10-24

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. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 2014-08-04
Decision date: 2014-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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