K151100 is an FDA 510(k) clearance for the U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System. 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 September 29, 2015, 158 days after receiving the submission on April 24, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K151100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2015 |
| Decision Date | September 29, 2015 |
| Days to Decision | 158 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 |