510(k) K093459— ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01

Substantially Equivalent

Phadia US, Inc.

Clearance details

Applicant: Phadia US, Inc.
Product code: Code MST
Advisory panel: Immunology
Date received: 2009-11-06
Decision date: 2010-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

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