K-number	K072939
Device name	HE4 EIA, MODEL: 404-10 US
Applicant	Fujirebio Diagnostics,Inc.
Product code	OIU
Device class	Class II
Decision date	Jun 9, 2008
Decision	Substantially Equivalent
Regulation	866.6010

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HE4 EIA, MODEL: 404-10 US

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