The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Element Blood Glucose Monitoring System.
| Device ID | K113670 |
| 510k Number | K113670 |
| Device Name: | ELEMENT BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-13 |
| Decision Date | 2012-05-08 |
| Summary: | summary |