The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Rightest Blood Glucose Monitoring System, Model Gm100.
| Device ID | K081451 |
| 510k Number | K081451 |
| Device Name: | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BIONIME CORPORATION 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk 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 | 2008-05-23 |
| Decision Date | 2008-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883489001498 | K081451 | 000 |
| 20883489001423 | K081451 | 000 |
| 00883489001078 | K081451 | 000 |
| 20883489001065 | K081451 | 000 |