ELECSYS RUBELLA IGM IMMUNOASSAY— 510(k) K092322

Name: FDA 510(k) clearance K092322
Creator: U.S. Food and Drug Administration
Published: 2010-03-12

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K092322 for ELECSYS RUBELLA IGM IMMUNOASSAY, Substantially Equivalent on 2010-03-12. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2009-08-04
Decision date: 2010-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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