K082201 is an FDA 510(k) clearance for the G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by U. S. Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on February 20, 2009, 199 days after receiving the submission on August 5, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K082201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2008 |
| Decision Date | February 20, 2009 |
| Days to Decision | 199 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 |