K-number	K141803
Device name	IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
Applicant	Immunalysis Corporation
Product code	DJG
Device class	Class II
Decision date	Feb 12, 2015
Decision	Substantially Equivalent
Regulation	862.3650

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View the full FDA submission: accessdata.fda.gov

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IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY

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