Parsippany, NJ, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QRL | — | — | — | 2 | 2025-05-14 |
| NBW | System, Test, Blood Glucose, Over The Counter | Class II | Clinical Chemistry | 2 | 2024-08-27 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class II | General, Plastic Surgery | 1 | 2024-08-15 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-05-14 | K250813 | MICROLET®NEXT 2 Lancing Device | QRL | — | — |
| 2024-08-27 | K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | NBW | Class II | Clinical Chemistry |
| 2024-08-15 | K241810 | MICROLET®NEXT Lancet | QRK | Class II | General, Plastic Surgery |
| 2022-11-18 | K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | NBW | Class II | Clinical Chemistry |
| 2022-06-03 | K220633 | MICROLET NEXT lancing device, MICROLET Lancet | QRL | — | — |