Name: Predicase
Price: 199 USD

K-number	K180255
Device name	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Applicant	Hangzhou Clongene Biotech Co., Ltd.
Product code	PTH
Device class	Class II
Decision date	Feb 28, 2018
Decision	Substantially Equivalent
Regulation	862.3150

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Source

View the full FDA submission: accessdata.fda.gov

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CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

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