510(k) K122181
- Device
- EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
- Applicant
- VISGENEER, INC.
- 510(k) number
- K122181
- Product code
- NBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-15
- Date received
- 2012-07-23
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK YANG
- Address
- # 188, Sec. 3 Gongdao 5th Rd. Hsinchu City TW 30069 30069
FDA Registration Numbers#
- 3008789114
- 1810909
- 1219029
- 3005644014
- 3006537560
- 3011393376
- 3010852191
- 3022346573
- 3013729860
- 3004193489
- 3010713600
- 3003902721
- 3005798905
- 3004146366
- 3008700497
- 3011536730
- 9710492
- 3009456923
- 3004637226
- 3042364147
- 3010564249
- 3006733253
- 3017086896
- 1832216
- 3009171251
- 3043513123
- 3012725363
- 3006755541
- 3032948391
- 3003366417
- 3014302067
- 3012188053
- 3011420269
- 3017500903
- 3001058982
- 2954323
- 3001452053
- 3005862821
- 3013223546
- 9610126
- 1220649
- 3015188281
- 3010830834
- 2030633
- 9612841
- 1616487
- 3008959428
- 3013957847
- 3008780388
- 3002807314
- 3034603279
- 1649661
- 3003674698
- 3011979858
- 3022147580
- 3002736372
- 3011061417
- 3009129531
- 3007382160
- 1181121
- 3017520431
- 3020885868
- 3043025312
- 3005706626
- 3015109923
- 3031259044
- 9710595
- 3008606429
- 1000115322
- 3007384659
- 3003741676
- 3004009431
- 3004176168
- 9615507
- 3008514395
- 3045492872
- 3004145393
- 3015997711
- 3010622184
- 3024379416
Source Documents#
Other 510(k) Records For Product Code NBW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K223722 | MIO Blood Glucose Monitoring System | Mio Labs, Inc. | 2023-06-28 |
Legacy Summary#
summary
FDA Review#
Decision Summary