K-number	K960091
Device name	ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
Applicant	Helix Diagnostics, Inc.
Product code	LRM
Device class	Class II
Decision date	Mar 20, 1996
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT

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