The following data is part of a premarket notification filed by Agamatrix Inc with the FDA for Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application.
| Device ID | K130535 |
| 510k Number | K130535 |
| Device Name: | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | AGAMATRIX INC 7C RAYMOND AVE Salem, NH 03079 |
| Contact | William H Mcgrail |
| Correspondent | William H Mcgrail AGAMATRIX INC 7C RAYMOND AVE Salem, NH 03079 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-01 |
| Decision Date | 2013-04-17 |
| Summary: | summary |