Name: Predicase
Price: 199 USD

K-number	K131110
Device name	ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
Applicant	Co-Innovation Biotech Co., Ltd.
Product code	DKZ
Device class	Class II
Decision date	Jan 15, 2014
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD

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