The following data is part of a premarket notification filed by Agamatrix, Inc. with the FDA for One Drop Blood Glucose Monitoring System.
| Device ID | K161834 |
| 510k Number | K161834 |
| Device Name: | One Drop Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | AgaMatrix, Inc. 7C Raymond Ave. Salem, NH 03079 |
| Contact | David Olsen |
| Correspondent | David Olsen 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 | 2016-07-05 |
| Decision Date | 2016-11-30 |
| Summary: | summary |