K-number	K181329
Device name	EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
Applicant	Phadia AB
Product code	MSV
Device class	Class II
Decision date	Jun 25, 2018
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

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