510(k) K140225— ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

Substantially Equivalent

Phadia US, Inc.

Clearance details

Applicant: Phadia US, Inc.
Product code: Code MOB
Advisory panel: Immunology
Date received: 2014-01-29
Decision date: 2014-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg Im Breisgau, DE

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