K162282 is an FDA 510(k) clearance for the CardioChek Plus Test System, CardioChek Home Test System. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 22, 2016, 129 days after receiving the submission on August 15, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K162282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2016 |
| Decision Date | December 22, 2016 |
| Days to Decision | 129 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGA - Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |