K151545

Substantially Equivalent

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
Advisory panel: Clinical Chemistry
Date received: 2015-06-09
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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