K-number	K944505
Device name	DIASTAT ENA SINGLE WELL SCREEN KIT
Applicant	Shield Diagnostics, Ltd.
Product code	LLL
Device class	Class II
Decision date	Nov 21, 1994
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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DIASTAT ENA SINGLE WELL SCREEN KIT

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