The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Element Plus Blood Glucose Monitoring System.
| Device ID | K103021 |
| 510k Number | K103021 |
| Device Name: | ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | INFOPIA CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung INFOPIA CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2011-11-04 |
| Summary: | summary |