K-number	K141375
Device name	ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
Applicant	Phadia US, Inc.
Product code	DBM
Device class	Class II
Decision date	Feb 13, 2015
Decision	Substantially Equivalent
Regulation	866.5090

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ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

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