Name: Predicase
Price: 199 USD

K-number	K153693
Device name	Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Applicant	Immunalysis Corporation
Product code	LAF
Device class	Class II
Decision date	Mar 18, 2016
Decision	Substantially Equivalent
Regulation	862.3610

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Source

View the full FDA submission: accessdata.fda.gov

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Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

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