Name: Predicase
Price: 199 USD

K-number	K111560
Device name	WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST
Applicant	Guangzhou Wondfo Biotech Co., Ltd.
Product code	DKZ
Device class	Class II
Decision date	Jul 15, 2011
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST

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