Name: Predicase
Price: 199 USD

K-number	K151100
Device name	U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
Applicant	Taidoc Technology Corporation
Product code	NBW
Device class	Class II
Decision date	Sep 29, 2015
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System

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