K081609 is an FDA 510(k) clearance for the CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on July 2, 2008, 23 days after receiving the submission on June 9, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K081609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2008 |
| Decision Date | July 02, 2008 |
| Days to Decision | 23 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 |