K031843 is an FDA 510(k) clearance for the MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 3, 2003, 17 days after receiving the submission on June 16, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K031843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2003 |
| Decision Date | July 03, 2003 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |