K101597 is an FDA 510(k) clearance for the WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Agamatrix (Salem, US). The FDA issued a Cleared decision on October 18, 2010, 132 days after receiving the submission on June 8, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K101597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2010 |
| Decision Date | October 18, 2010 |
| Days to Decision | 132 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 |