K-number	K173792
Device name	EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
Applicant	Phadia AB
Product code	MOB
Device class	Class II
Decision date	Mar 13, 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 PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

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