K161738 is an FDA 510(k) clearance for the FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on November 10, 2016, 140 days after receiving the submission on June 23, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K161738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2016 |
| Decision Date | November 10, 2016 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| 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 |