2 devices · 2 companies · 2015 to 2016
Product code NBW: System, Test, Blood Glucose, Over The Counter
2 devices under product code NBW, 2015 to 2016, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
System, Test, Blood Glucose, Over The Counter. 21 CFR 862.1345, Class II. MAUDE held 432,413 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| One Drop Blood Glucose Monitoring SystemK161834 · 510(k) | AgaMatrix, Inc. | Clinical Chemistry | database entry | |
| Dario Blood Glucose Monitoring SystemK150817 · 510(k) | LabStyle Innovations Ltd. | Clinical Chemistry | database entry |
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