510(k) K181329— EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

Substantially Equivalent

Phadia AB

Clearance details

Applicant: Phadia AB
Product code: Code MSV
Advisory panel: Immunology
Date received: 2018-05-18
Decision date: 2018-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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