K061431 is an FDA 510(k) clearance for the EASYGLUCO, MODEL IGM-0002 G2. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by U. S. Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on January 12, 2007, 233 days after receiving the submission on May 24, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K061431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2006 |
| Decision Date | January 12, 2007 |
| Days to Decision | 233 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 |