K-number	K940510
Device name	ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
Applicant	Helix Diagnostics, Inc.
Product code	LKP
Device class	Class II
Decision date	Apr 20, 1994
Decision	Substantially Equivalent
Regulation	866.5100

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ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT

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