NBW
- Product code
- NBW
- Device name
- System, Test, Blood Glucose, Over The Counter
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1345
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 13
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 510 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (13)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260545 | 2026-08-27 | Ascensia Diabetes Care | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; … | |
| K262116 | 2026-07-23 | Trividia Health, Inc. | TRUE METRIX Self Monitoring Blood Glucose System | |
| K250085 | 2025-10-10 | ACON Laboratories, Inc. | On Call® Sure GK Blood Glucose & Ketone Monitoring S… | — |
| K243060 | 2025-01-30 | Guangdong Transtek Medical Electronics… | TeleRPM Gen2 Blood Glucose Monitoring System | FDA |
| K240637 | 2024-11-04 | Bionime Corporation | RIGHTEST Blood Glucose Monitoring System Max Tel | |
| K240640 | 2024-10-08 | Sejoy Biomedical Co., Ltd. | Sejoy Blood Glucose Monitoring System; Sejoy Advance… | |
| K241787 | 2024-08-27 | Ascensia Diabetes Care U.S., Inc. | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; … | FDA |
| K222126 | 2024-08-16 | Vivachek Biotech (Hangzhou) Co., Ltd. | VivaChek Fad Blood Glucose Monitoring System, VivaC… | |
| K241304 | 2024-06-06 | Agamatrix | WaveSense Jazz Blood Glucose Monitoring System | |
| K231679 | 2024-02-23 | Ascensia Diabetes Care | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | |
| K231192 | 2024-01-19 | Bionime Corporation | RIGHTEST Blood Glucose Monitoring System Max Tel | |
| K233058 | 2023-12-22 | Vivachek Biotech (Hangzhou) Co., Ltd. | VivaChek Link Plus Blood Glucose Monitoring System | |
| K231476 | 2023-12-01 | Sinocare, Inc. | TRUENESS AIR Blood Glucose Monitoring System; TRUEN… |
Official FDA classification page: NBW
Classification and pathway per current FDA publications. Data from openFDA (CC0).