K-number	K182747
Device name	EliA RF IgM Immunoassay
Applicant	Phadia AB
Product code	DHR
Device class	Class II
Decision date	Dec 18, 2018
Decision	Substantially Equivalent
Regulation	866.5775

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Source

View the full FDA submission: accessdata.fda.gov

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EliA RF IgM Immunoassay

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