The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Bionime Rightest Blood Glucose Monitoring System, Model Gm650.
| Device ID | K120423 |
| 510k Number | K120423 |
| Device Name: | BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BIONIME CORPORATION 2700 LAPAZ ROAD SUITE 266B Mission Viejo, CA 92691 |
| Contact | Feng-yu Lee |
| Correspondent | Feng-yu Lee BIONIME CORPORATION 2700 LAPAZ ROAD SUITE 266B Mission Viejo, CA 92691 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-13 |
| Decision Date | 2012-08-03 |
| Summary: | summary |