K-number	K871144
Device name	TANGENT SYSTEM(TM) ANA PROFILE TEST KIT
Applicant	Vitrotec Laboratories, Inc.
Product code	DHN
Device class	Class II
Decision date	Apr 29, 1987
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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TANGENT SYSTEM(TM) ANA PROFILE TEST KIT

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