K140068 is an FDA 510(k) clearance for the CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 22, 2015, 494 days after receiving the submission on January 13, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K140068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2014 |
| Decision Date | May 22, 2015 |
| Days to Decision | 494 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |