FDA 510(k)

CardioChek Plus Test System; CardioChek Plus Home Test System

K-Number: K193406 · 2022-02-26

ApplicantPolymer Technology Systems, Inc. D/B/A Pts Diagnostics

Decision Date2022-02-26

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CardioChek Plus Test System; CardioChek Plus 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 2022-02-26 under approval number K193406. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

CardioChek Plus Test System; CardioChek Plus Home Test System is a medical device that received FDA 510(k) clearance on 2022-02-26. It is manufactured by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The 510(k) number is K193406.

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

CardioChek Plus Test System; CardioChek Plus Home Test System received FDA 510(k) clearance on 2022-02-26, under approval number K193406.

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

CardioChek Plus Test System; CardioChek Plus 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 Plus Home Test System?

The FDA product code for CardioChek Plus Test System; CardioChek Plus Home Test System is NBW. This falls under the OB/GYN category.

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

K162282CardioChek Plus Test System, CardioChek Home Test System K182781PTS Professional Chemistry Kit

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Official Source

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