The following data is part of a premarket notification filed by Hypoguard Usa, Inc. with the FDA for Assure Pro Blood Glucose Monitoring System, Model 460001.
| Device ID | K053079 |
| 510k Number | K053079 |
| Device Name: | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | HYPOGUARD USA, INC. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Bruce A Macfarlane |
| Correspondent | Bruce A Macfarlane HYPOGUARD USA, INC. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-02 |
| Decision Date | 2006-03-28 |
| Summary: | summary |