K-number	K051578
Device name	IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
Applicant	Immunalysis Corporation
Product code	DIO
Device class	Class II
Decision date	Nov 18, 2005
Decision	Substantially Equivalent
Regulation	862.3250

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View the full FDA submission: accessdata.fda.gov

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IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS

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