ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY— 510(k) K131605

Name: FDA 510(k) clearance K131605
Creator: U.S. Food and Drug Administration
Published: 2014-02-28

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K131605 for ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY, Substantially Equivalent on 2014-02-28. 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: 2013-06-03
Decision date: 2014-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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