K083570 is an FDA 510(k) clearance for the U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on March 11, 2009, 98 days after receiving the submission on December 3, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K083570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2008 |
| Decision Date | March 11, 2009 |
| Days to Decision | 98 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |