510(k) K141292
- Device
- Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, And GE300 Talking Blood Glucose Monitoring System
- Applicant
- BIONIME COPORATION
- 510(k) number
- K141292
- Product code
- NBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-06-09
- Date received
- 2014-05-19
- 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
- Feng-Yu Lee
- Address
- 29222 Rancho Viejo Rd. Suite 218 San Juan Capistrano CA US 92675 92675
FDA Registration Numbers#
- 9611444
- 3007171717
- 3006537560
- 3004637226
- 1000113657
- 2029275
- 3003674698
- 3030311186
- 3008789114
- 1832216
- 3022346573
- 3033530347
- 3009901017
- 3007499349
- 3005644014
- 3004130086
- 3002807314
- 3011121740
- 3011061417
- 3016525500
- 3003600763
- 3010852191
- 3030186688
- 3014353121
- 3005862821
- 3033394445
- 9615507
- 3011979858
- 3015997711
- 1832816
- 3011065399
- 3030978471
- 2954323
- 3003422726
- 3004167884
- 3007031103
- 3009171251
- 1219029
- 3003741676
- 3013957847
- 3005393828
- 3016863723
- 3010564249
- 3007594734
- 3017550662
- 3015188281
- 3004043187
- 3008573045
- 1220477
- 3014353045
- 3007421145
- 3012014399
- 3007710663
- 3021286079
- 3004009431
- 3015109923
- 3004183148
- 3022147580
- 3005621222
- 3005627859
- 3017500903
- 1450743
- 2953359
- 3008514395
- 1220649
- 3003917514
- 3013160357
- 3042026207
- 3042364147
- 3014302067
- 3017520431
- 2030633
- 3003902721
- 1000134386
- 3011536730
- 3017086896
- 3009204541
- 3017548799
- 3026260647
- 3032948391
Source Documents#
Other 510(k) Records For Product Code NBW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | 2023-08-10 |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | 2023-08-10 |
| K223722 | MIO Blood Glucose Monitoring System | Mio Labs, Inc. | 2023-06-28 |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-12-21 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases