The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Modification To Rightest Blood Glucose Monitoring System.
| Device ID | K053635 |
| 510k Number | K053635 |
| Device Name: | MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-29 |
| Decision Date | 2006-02-21 |
| Summary: | summary |