The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Element Tm Lite Blood Glucose Monitoring System.
| Device ID | K133045 |
| 510k Number | K133045 |
| Device Name: | ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | INFOPIA CO., LTD #891 Hogye-dong, Dongan-gu Anyang, Gyeonggi, KR 431-080 |
| Contact | Seonmi Shin |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2014-04-10 |
| Summary: | summary |