K080636 is an FDA 510(k) clearance for the DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Hubdic Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on February 13, 2009, 344 days after receiving the submission on March 6, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K080636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2008 |
| Decision Date | February 13, 2009 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGA - Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |