Name: Predicase
Price: 199 USD

K-number	K112916
Device name	TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM
Applicant	Tyson Bioresearch, Inc.
Product code	NBW
Device class	Class II
Decision date	Aug 21, 2012
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM

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