The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Glucolab Blood Glucose Monitoring System.
| Device ID | K051285 |
| 510k Number | K051285 |
| Device Name: | GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | INFOPIA CO., LTD 889-3, KWANYANG2-DONG, DONGAN-GU Anyang Kvunggi, KR 431-716 |
| Contact | Byeong Woo Bae |
| Correspondent | Byeong Woo Bae INFOPIA CO., LTD 889-3, KWANYANG2-DONG, DONGAN-GU Anyang Kvunggi, KR 431-716 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-17 |
| Decision Date | 2005-08-02 |
| Summary: | summary |