The following data is part of a premarket notification filed by Glucoplus Inc with the FDA for Glucoplus Blood Glucose Monitoring System.
| Device ID | K061234 |
| 510k Number | K061234 |
| Device Name: | GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | GLUCOPLUS INC 315 PARKVIEW WAY Newtown, PA 18940 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman GLUCOPLUS INC 315 PARKVIEW WAY Newtown, PA 18940 |
| 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 | 2006-05-02 |
| Decision Date | 2006-10-30 |
| Summary: | summary |