510(k) K152534
- Device
- Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Gluc
- Applicant
- TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
- 510(k) number
- K152534
- Product code
- NBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-21
- Date received
- 2015-09-04
- 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
- CHAE CHUNG LYUEL
- Address
- # 35 And 37, Yingcheng St. Hangu CN 300480 300480
FDA Registration Numbers#
- 3010131137
- 3012421607
- 3015188281
- 3010852191
- 3008959428
- 3007499349
- 3005644014
- 3017086896
- 3002736372
- 3002807314
- 1832216
- 3016525500
- 1219029
- 3004146366
- 3003422726
- 3011393376
- 3005627859
- 3001452053
- 3011121740
- 3007710663
- 3006733253
- 3011420269
- 3015997711
- 3030311186
- 3008606429
- 3009204541
- 1649661
- 3008824097
- 3008514395
- 3011536730
- 3013223546
- 3008700497
- 9615507
- 3010830834
- 3011061417
- 3015058854
- 3006532271
- 3015347724
- 3022418645
- 3031259044
- 3024512705
- 1220649
- 2030633
- 3005862821
- 3007031103
- 3013472743
- 3038419886
- 3005395953
- 3013298431
- 3007382160
- 3031789039
- 3004193489
- 3011213605
- 3022346573
- 3004043187
- 3007421145
- 1220477
- 9611444
- 3013160357
- 3030186688
- 9710595
- 3004009431
- 3007134734
- 3024379416
- 3012133212
- 1450743
- 1000134386
- 9616530
- 3021841051
- 3008780388
- 3005798905
- 3012014399
- 3018940143
- 3043013796
- 3005706626
- 1450662
- 3042301847
- 3008573045
- 3011979858
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#
summary
FDA Review#
Decision Summary