K-number	K130275
Device name	QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
Applicant	Tianjin New Bay Bioresearch Co., Ltd.
Product code	DJG
Device class	Class II
Decision date	Sep 26, 2013
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST

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