Name: Predicase
Price: 199 USD

K-number	K112071
Device name	WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
Applicant	Guangzhou Wondfo Biotech Co., Ltd.
Product code	DIO
Device class	Class II
Decision date	Sep 23, 2011
Decision	Substantially Equivalent
Regulation	862.3250

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Source

View the full FDA submission: accessdata.fda.gov

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WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P

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