ELECSYS RUBELLA IGG IMMUNOASSAY— 510(k) K072617

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K072617 for ELECSYS RUBELLA IGG IMMUNOASSAY, Substantially Equivalent on 2008-12-05. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LFX
Advisory panel: Microbiology
Date received: 2007-09-17
Decision date: 2008-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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