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FDA 510(k)

CardioChek Plus Test System, CardioChek Home Test System

K-Number: K162282 · 2016-12-22

ApplicantPolymer Technology Systems, Inc. D/B/A Pts Diagnostics
Decision Date2016-12-22
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CardioChek Plus Test System, CardioChek Home Test System is a medical device manufactured by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. It received FDA 510(k) clearance on 2016-12-22 under approval number K162282. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

CardioChek Plus Test System, CardioChek Home Test System is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The 510(k) number is K162282.

When was CardioChek Plus Test System, CardioChek Home Test System approved by the FDA?

CardioChek Plus Test System, CardioChek Home Test System received FDA 510(k) clearance on 2016-12-22, under approval number K162282.

What company makes CardioChek Plus Test System, CardioChek Home Test System?

CardioChek Plus Test System, CardioChek Home Test System is manufactured by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics.

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

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

Other Devices by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

K182781PTS Professional Chemistry Kit K193406CardioChek Plus Test System; CardioChek Plus Home Test System

Related Devices (Code: CGA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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