Name: Predicase
Price: 199 USD

K-number	K093175
Device name	WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES
Applicant	Guangzhou Wondfo Biotech Co., Ltd.
Product code	DJG
Device class	Class II
Decision date	Aug 25, 2010
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES

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