K113768 is an FDA 510(k) clearance for the U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM. This device is classified as a Glucose Dehydrogenase, Glucose (Class II - Special Controls, product code LFR).
Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on April 12, 2012, 113 days after receiving the submission on December 21, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K113768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2011 |
| Decision Date | April 12, 2012 |
| Days to Decision | 113 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LFR — Glucose Dehydrogenase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |