The following data is part of a premarket notification filed by Agamatrix with the FDA for Liberty Blood Glucose Monitoring System, Model 8000-0067.
| Device ID | K063409 |
| 510k Number | K063409 |
| Device Name: | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | AGAMATRIX 10 MAOR PARKWAY Salem, NH 03079 |
| Contact | Connie Hertel |
| Correspondent | Connie Hertel AGAMATRIX 10 MAOR PARKWAY Salem, NH 03079 |
| 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 | 2006-11-13 |
| Decision Date | 2007-01-12 |
| Summary: | summary |