K-number	K101319
Device name	IMMULISA DSDNA ANTIBODY ELISA
Applicant	Immco Diagnostics, Inc.
Product code	LRM
Device class	Class II
Decision date	Dec 9, 2010
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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IMMULISA DSDNA ANTIBODY ELISA

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