510(k) K083628
- Device
- GLUCODR AUTO SYSTEM
- Applicant
- ALL MEDICUS CO., LTD
- 510(k) number
- K083628
- Product code
- NBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-01
- Date received
- 2008-12-08
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARGARET KIM
- Address
- 7068 Dong-Il Techno Town 7th 823 Gwanyang 2-Dong Anyang, Gyeonggi-Do KR 431-062 431-062
FDA Registration Numbers#
- 3010713600
- 3003366417
- 9616936
- 3013298431
- 3008824097
- 3015967131
- 3018940143
- 3031789039
- 3003600763
- 3021611414
- 3005706626
- 3009901017
- 3009456923
- 3012133212
- 2954323
- 3022346573
- 3015525148
- 9611444
- 3003674698
- 1832216
- 3042301847
- 3011065399
- 3030979885
- 3045492872
- 1220649
- 3042364147
- 3015188281
- 3007421145
- 3004183148
- 3005644014
- 3007382160
- 9610126
- 1219029
- 3005621222
- 3003902721
- 3013223546
- 3011061417
- 1649661
- 3011420269
- 3008573045
- 3004167884
- 3020885868
- 3030311186
- 3045951983
- 3013472743
- 3013160357
- 3013729860
- 3015058854
- 3014353045
- 2953359
- 9710492
- 1000113657
- 3033530347
- 3007363438
- 3017520431
- 3030171742
- 3011393376
- 3006537560
- 3003741676
- 3005627859
- 3005393828
- 3005395953
- 1810909
- 3007031103
- 9616530
- 3004101980
- 3009129531
- 3004145393
- 3004146366
- 2030633
- 3008780388
- 3024379416
- 3004009431
- 3006755541
- 3004130086
- 3043513123
- 3006371704
- 3010131137
- 3022418645
- 3015997711
Source Documents#
Other 510(k) Records For Product Code NBW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260738 | Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System | Changsha Sinocare, Inc. | 2026-10-30 |
| K261293 | EASYMAX Voice Blood Glucose Monitoring System | EPS Bio Technology Corp. | 2026-10-23 |
| K260687 | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-10-09 |
| K260689 | CVS Advanced PLUS Blood Glucose Monitoring System | I-Sens, Inc. | 2026-10-02 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary