Name: Predicase
Price: 199 USD

K-number	K141320
Device name	LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
Applicant	Lin-Zhi International, Inc.
Product code	LDJ
Device class	Class II
Decision date	May 28, 2015
Decision	Substantially Equivalent
Regulation	862.3870

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Source

View the full FDA submission: accessdata.fda.gov

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LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls

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