ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY— 510(k) K131821

Substantially Equivalent

Phadia US, Inc.

FDA 510(k) clearance K131821 for ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY, Substantially Equivalent on 2013-12-23. Applicant: Phadia US, Inc..

Clearance details

Applicant: Phadia US, Inc.
Product code: Code MID
Advisory panel: Immunology
Date received: 2013-06-20
Decision date: 2013-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

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