K-number	K003054
Device name	AUTOSTAT II ENA-6 PROFILE ELISA
Applicant	Cogent Diagnotics , Ltd.
Product code	LLL
Device class	Class II
Decision date	Oct 13, 2000
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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AUTOSTAT II ENA-6 PROFILE ELISA

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