The following data is part of a premarket notification filed by All Medicus Co., Ltd with the FDA for Glucodr Plus System, Model Agm-3000.
| Device ID | K082328 |
| 510k Number | K082328 |
| Device Name: | GLUCODR PLUS SYSTEM, MODEL AGM-3000 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ALL MEDICUS CO., LTD 823 GWANYANG 2-DONG DONGAN-GU Anyang, Gyeonggi-do, KR 431-062 |
| Contact | Margaret Kim |
| Correspondent | Margaret Kim ALL MEDICUS CO., LTD 823 GWANYANG 2-DONG DONGAN-GU Anyang, Gyeonggi-do, KR 431-062 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-14 |
| Decision Date | 2009-02-27 |
| Summary: | summary |