The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Envision Blood Glucose Test System.
| Device ID | K082020 |
| 510k Number | K082020 |
| Device Name: | ENVISION BLOOD GLUCOSE TEST SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | INFOPIA CO., LTD 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Correspondent | Maria F Griffin INFOPIA CO., LTD 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-16 |
| Decision Date | 2008-12-24 |
| Summary: | summary |