K-number	K182353
Device name	EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
Applicant	Phadia AB
Product code	LJM
Device class	Class II
Decision date	Nov 27, 2018
Decision	Substantially Equivalent
Regulation	866.5100

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Source

View the full FDA submission: accessdata.fda.gov

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EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay

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