The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Rightest Blood Glucose Monitoring System, Model Gm550.
| Device ID | K092052 |
| 510k Number | K092052 |
| Device Name: | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 |
| 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 |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-07 |
| Decision Date | 2010-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883489310309 | K092052 | 000 |
| 10612479212784 | K092052 | 000 |
| 10612479212777 | K092052 | 000 |
| 20883489001140 | K092052 | 000 |
| 20883489001164 | K092052 | 000 |
| 00883489001177 | K092052 | 000 |
| 20883489001201 | K092052 | 000 |
| 20883489001225 | K092052 | 000 |
| 20883489001249 | K092052 | 000 |
| 20883489001263 | K092052 | 000 |
| 20883489001287 | K092052 | 000 |
| 20883489001348 | K092052 | 000 |
| 20883489001362 | K092052 | 000 |
| 20883489001386 | K092052 | 000 |
| 00883489001399 | K092052 | 000 |
| 00883489001436 | K092052 | 000 |
| 00883489001443 | K092052 | 000 |
| 00883489310293 | K092052 | 000 |
| 00883489002501 | K092052 | 000 |