Name: Predicase
Price: 199 USD

K-number	K150356
Device name	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Applicant	Healgen Scientific,, LLC
Product code	JXM
Device class	Class II
Decision date	May 13, 2015
Decision	Substantially Equivalent
Regulation	862.3170

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Source

View the full FDA submission: accessdata.fda.gov

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Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

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