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

Name: FDA 510(k) clearance K131821
Creator: U.S. Food and Drug Administration
Published: 2013-12-23

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.. Device class: 2.

Clearance details

Applicant: Phadia US, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2013-06-20
Decision date: 2013-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

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