The following data is part of a premarket notification filed by Sd Biosensor with the FDA for Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring System.
| Device ID | K123517 |
| 510k Number | K123517 |
| Device Name: | GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | SD BIOSENSOR 55 NORTHERN BLVD Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah SD BIOSENSOR 55 NORTHERN BLVD 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-14 |
| Decision Date | 2014-01-17 |
| Summary: | summary |