The following data is part of a premarket notification filed by All Medicus Co., Ltd with the FDA for Glucodr Auto System.
| Device ID | K083628 |
| 510k Number | K083628 |
| Device Name: | GLUCODR AUTO SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ALL MEDICUS CO., LTD 7068 DONG-IL TECHNO TOWN 7TH 823 GWANYANG 2-DONG Anyang, Gyeonggi-do, KR 431-062 |
| Contact | Margaret Kim |
| Correspondent | Margaret Kim ALL MEDICUS CO., LTD 7068 DONG-IL TECHNO TOWN 7TH 823 GWANYANG 2-DONG 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 | 2008-12-08 |
| Decision Date | 2009-05-01 |
| Summary: | summary |