The following data is part of a premarket notification filed by Hypoguard Usa, Inc. with the FDA for Advance Micro-draw Blood Glucose Monitoring System, Model 411100.
| Device ID | K041881 |
| 510k Number | K041881 |
| Device Name: | ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 |
| 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 | 2004-07-12 |
| Decision Date | 2005-03-25 |
| Summary: | summary |