K-number	K970198
Device name	IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
Applicant	Scimedx Corp.
Product code	DHN
Device class	Class II
Decision date	Feb 20, 1997
Decision	Substantially Equivalent
Regulation	866.5100

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IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES

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