EUROIMMUN ANTI-ENA POOL ELISA (IGG)— 510(k) K112996

Name: FDA 510(k) clearance K112996
Creator: U.S. Food and Drug Administration
Published: 2013-04-09

Substantially Equivalent

Euroimmun US

FDA 510(k) clearance K112996 for EUROIMMUN ANTI-ENA POOL ELISA (IGG), Substantially Equivalent on 2013-04-09. Applicant: Euroimmun US. Device class: 2.

Clearance details

Applicant: Euroimmun US
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2011-10-07
Decision date: 2013-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.