K112996

Substantially Equivalent

EUROIMMUN ANTI-ENA POOL ELISA (IGG)

Applicant: Euroimmun US
Product code: LLL
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 ↗

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