One Drop Blood Glucose Monitoring System is an AI-enabled medical device from AgaMatrix, Inc., listed by FDA (510(k), K161834) with a decision date of 2016-11-30. Review panel: Clinical Chemistry.
| FDA submission number | K161834 |
|---|---|
| Pathway | 510(k) |
| Company | AgaMatrix, Inc. |
| Review panel (specialty) | Clinical Chemistry |
| FDA decision date | 2016-11-30 |
| Decision | Substantially Equivalent |
| Product code | NBW |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Device class | 2 |
| Regulation number | 862.1345 |
| Review time (calendar days) | 148 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.