K062800 is an FDA 510(k) clearance for the CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO. 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 (San Chung, Taipei, TW). The FDA issued a Cleared decision on January 12, 2007, 115 days after receiving the submission on September 19, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K062800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2006 |
| Decision Date | January 12, 2007 |
| Days to Decision | 115 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 |