Name: Predicase
Price: 199 USD

K-number	K163704
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	Aug 2, 2017
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.