The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Rightest Blood Glucose Monitoring System Gm700 Ge Ge200 Blood Glucose Monitoring System Rightest Blood Glucose Monitorin.
| Device ID | K123008 |
| 510k Number | K123008 |
| Device Name: | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BIONIME CORPORATION 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah BIONIME CORPORATION 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11021 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-27 |
| Decision Date | 2013-01-25 |
| Summary: | summary |