K-number	K950414
Device name	HEMAGEN ENA SM/RMP KIT (EIA METHOD)
Applicant	Hemagen Diagnostics, Inc.
Product code	LLL
Device class	Class II
Decision date	Mar 29, 1995
Decision	Substantially Equivalent
Regulation	866.5100

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HEMAGEN ENA SM/RMP KIT (EIA METHOD)

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