K-number	K802527
Device name	TEST KIT FOR DETECTION OF ANTINUCLEAR
Applicant	Bartels & Stout, Inc.
Product code	DHN
Device class	Class II
Decision date	Jan 5, 1981
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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TEST KIT FOR DETECTION OF ANTINUCLEAR

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