510(k) K141375— ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

Substantially Equivalent

Phadia US, Inc.

Clearance details

Applicant: Phadia US, Inc.
Product code: Code DBM
Advisory panel: Immunology
Date received: 2014-05-27
Decision date: 2015-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg Im Breisgau, DE

Download summary PDF View on FDA.gov ↗

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