CardioChek Plus Test System, CardioChek Home Test System

FDA 510(k) K162282 · Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

Substantially Equivalent

510(k) numberK162282

Submission

Device name
CardioChek Plus Test System, CardioChek Home Test System
Applicant
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
Indianapolis, IN, US
Received
August 15, 2016
Decision date
December 22, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CGA – Glucose Oxidase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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Questions and answers

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

CardioChek Plus Test System, CardioChek Home Test System (K162282) received a 510(k) decision of Substantially Equivalent on December 22, 2016, 129 days after the submission was received.

What is the product code of K162282?

The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.