The following data is part of a premarket notification filed by Bioptik Technology, Inc. with the FDA for Easymate Blood Glucose Monitoring System.
| Device ID | K053312 |
| 510k Number | K053312 |
| Device Name: | EASYMATE BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BIOPTIK TECHNOLOGY, INC. 6833 ST. LAWRENCE STREET Plano, TX 75024 |
| Contact | Eric Luo |
| Correspondent | Eric Luo BIOPTIK TECHNOLOGY, INC. 6833 ST. LAWRENCE STREET Plano, TX 75024 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-28 |
| Decision Date | 2006-03-01 |