K-number	K993839
Device name	ENA PROFILE ELISA TEST SYSTEM
Applicant	Trinity Biotech USA
Product code	LLL
Device class	Class II
Decision date	Jan 12, 2000
Decision	Substantially Equivalent
Regulation	866.5100

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Source

View the full FDA submission: accessdata.fda.gov

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ENA PROFILE ELISA TEST SYSTEM

Everything you need for a 510(k) submission. Nothing you don't.