The following data is part of a premarket notification filed by All Medicus Co., Ltd with the FDA for Glucodr Supersensor System.
| Device ID | K050985 |
| 510k Number | K050985 |
| Device Name: | GLUCODR SUPERSENSOR SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ALL MEDICUS CO., LTD 7106 DONG-IL TECHO TOWN 7TH 823 KWANYANG DONG DONGAN-GU Anyang, Gyeonggi-do, KR 431-062 |
| Contact | Je Young Chang |
| Correspondent | Je Young Chang ALL MEDICUS CO., LTD 7106 DONG-IL TECHO TOWN 7TH 823 KWANYANG 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 | 2005-04-19 |
| Decision Date | 2005-10-07 |
| Summary: | summary |