Name: Predicase
Price: 199 USD

K-number	K151203
Device name	Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
Applicant	Immunalysis Corporation
Product code	LDJ
Device class	Class II
Decision date	Jun 5, 2015
Decision	Substantially Equivalent
Regulation	862.3870

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Source

View the full FDA submission: accessdata.fda.gov

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Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set

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