Name: Predicase
Price: 199 USD

K-number	K101509
Device name	U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
Applicant	Taidoc Technology Corporation
Product code	NBW
Device class	Class II
Decision date	Jun 27, 2011
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-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM

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