The following data is part of a premarket notification filed by Tyson Bioresearch, Inc. with the FDA for Ez Smart-168 Glucose Monitoring System.
| Device ID | K052818 |
| 510k Number | K052818 |
| Device Name: | EZ SMART-168 GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TYSON BIORESEARCH, INC. 3000 K ST., N.W., STE 500 Washington, DC 20007 |
| Contact | David Rosen |
| Correspondent | David Rosen TYSON BIORESEARCH, INC. 3000 K ST., N.W., STE 500 Washington, DC 20007 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-04 |
| Decision Date | 2006-06-16 |
| Summary: | summary |