Name: Predicase
Price: 199 USD

K-number	K173345
Device name	TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
Applicant	Taidoc Technology Corporation
Product code	JIN
Device class	Class I
Decision date	May 4, 2018
Decision	Substantially Equivalent
Regulation	862.1435

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Source

View the full FDA submission: accessdata.fda.gov

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TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System

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