K141375

Substantially Equivalent

ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

Applicant: Phadia US, Inc.
Product 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

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