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FDA 510(k)

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

Número K: K151545 · 2016-12-22

RequerentePolymer Technology Systems, Inc.
Data da decisão2016-12-22
Código do produtoCHH
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Systems, Inc.. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K151545. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System?

CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K151545.

When did CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System receive FDA 510(k) clearance?

CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System received FDA 510(k) clearance on 2016-12-22, under 510(k) number K151545.

Who is the listed applicant for CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System?

The FDA 510(k) record lists Polymer Technology Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System?

The FDA product code for CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System is CHH.

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