Name: Predicase
Price: 199 USD

K-number	K150052
Device name	TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System
Applicant	Nipro Diagnostics, Inc.
Product code	NBW
Device class	Class II
Decision date	Mar 26, 2015
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System

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