510(k) K150942
- Device
- Contour Next USB Blood Glucose Monitoring System
- Applicant
- BAYER HEALTHCARE
- 510(k) number
- K150942
- Product code
- NBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-25
- Date received
- 2015-04-08
- Regulation
- 862.1345
- Classification name
- System, Test, Blood Glucose, Over The Counter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER L. GREGORY
- Address
- Diabetes Care 430 S. Beiger St. Mishawaka IN US 46544 46544
FDA Registration Numbers#
- 3005627859
- 3022147580
- 3004146366
- 3015997711
- 2531491
- 1037998
- 3013298431
- 3008810357
- 3015058854
- 3006532271
- 3030978471
- 3003422726
- 3001452053
- 3004193489
- 3007499349
- 3015967131
- 3005395953
- 3042364147
- 3015489159
- 1220649
- 3006371704
- 9616530
- 3008382007
- 3021286079
- 3008700497
- 3005798905
- 3018940143
- 3009204541
- 1616487
- 3024512705
- 3017520431
- 3017548799
- 3017550662
- 3015109923
- 3003366417
- 3005393828
- 3005862821
- 3004183148
- 1000134386
- 1000115322
- 3002807314
- 1649661
- 3013223546
- 3045752480
- 3014353045
- 3011979858
- 3004101980
- 3014302067
- 9612841
- 3011121740
- 3004130086
- 3013472743
- 3013896610
- 9611444
- 3007384659
- 3012421607
- 3045951983
- 2954323
- 1450743
- 3011191255
- 3010131137
- 3008573045
- 3014585508
- 1832216
- 3030979885
- 3009171251
- 3006537560
- 2953359
- 3024379416
- 3011065399
- 3004176168
- 3008514395
- 3012118659
- 1181121
- 3043013796
- 3004043187
- 3006733253
- 3007031103
- 3010564249
- 3012133212
Source Documents#
Other 510(k) Records For Product Code NBW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2026-08-27 |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | 2026-07-23 |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | ACON Laboratories, Inc. | 2025-10-10 |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | 2025-01-30 |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | 2024-11-04 |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. | 2024-10-08 |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2024-08-27 |
| K222126 | VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-08-16 |
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | Agamatrix | 2024-06-06 |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2024-02-23 |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | 2024-01-19 |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 |
| K231476 | TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System | Sinocare, Inc. | 2023-12-01 |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | 2023-08-10 |
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | 2023-08-10 |
Legacy Summary#
summary
FDA Review#
Decision Summary