NBW — System, Test, Blood Glucose, Over The Counter Class II
FDA product code NBW covers "System, Test, Blood Glucose, Over The Counter", a Class II medical device regulated under 21 CFR 862.1345. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NBW
- Device Class
- Class II
- Regulation Number
- 862.1345
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250085 | acon laboratories | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK | October 10, 2025 |
| K243060 | guangdong transtek medical electronics co | TeleRPM Gen2 Blood Glucose Monitoring System | January 30, 2025 |
| K240637 | bionime corporation | RIGHTEST Blood Glucose Monitoring System Max Tel | November 4, 2024 |
| K240640 | sejoy biomedical co | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitori | October 8, 2024 |
| K241787 | ascensia diabetes care u.s | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Gluc | August 27, 2024 |
| K222126 | vivachek biotech (hangzhou) co | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose | August 16, 2024 |
| K241304 | agamatrix | WaveSense Jazz Blood Glucose Monitoring System | June 6, 2024 |
| K231679 | ascensia diabetes care | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | February 23, 2024 |
| K231192 | bionime corporation | RIGHTEST Blood Glucose Monitoring System Max Tel | January 19, 2024 |
| K233058 | vivachek biotech (hangzhou) co | VivaChek Link Plus Blood Glucose Monitoring System | December 22, 2023 |
| K231476 | sinocare | TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitorin | December 1, 2023 |
| K213131 | roche diabetes care | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | August 10, 2023 |
| K230625 | i-sens | ReliOn Premier BLU Blood Glucose Monitoring System | August 10, 2023 |
| K223722 | mio labs | MIO Blood Glucose Monitoring System | June 28, 2023 |
| K222234 | apex biotechnology | GlucoSure ADVANCE Link Blood Glucose Monitoring System | December 21, 2022 |
| K223293 | ascensia diabetes care u.s | CONTOUR® NEXT GEN Blood Glucose Monitoring System | November 18, 2022 |
| K220421 | apex biotechnology | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring Sys | November 4, 2022 |
| K213061 | ok biotech co | SuperCheck Pro Blood Glucose Monitoring System | October 7, 2022 |
| K212248 | hmd biomedical | GlucoLeader Enhance 2 Blood Glucose Monitoring System | August 29, 2022 |
| K212140 | apex biotechnology | GlucoSure Link Blood Glucose Monitoring System | August 25, 2022 |