K-number	K980337
Device name	DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
Applicant	Helix Diagnostics, Inc.
Product code	LJM
Device class	Class II
Decision date	May 12, 1998
Decision	Substantially Equivalent
Regulation	866.5100

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DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM

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