Name: Predicase
Price: 199 USD

K-number	K151211
Device name	AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
Applicant	Assure Tech. Co., Ltd.
Product code	DIS
Device class	Class II
Decision date	Jun 4, 2015
Decision	Substantially Equivalent
Regulation	862.3150

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Source

View the full FDA submission: accessdata.fda.gov

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AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup

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