Name: Predicase
Price: 199 USD

K-number	K151545
Device name	CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
Applicant	Polymer Technology Systems, Inc.
Product code	CHH
Device class	Class I
Decision date	Dec 22, 2016
Decision	Substantially Equivalent
Regulation	862.1175

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System

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