The following data is part of a premarket notification filed by Diagnostic Devices, Inc. with the FDA for Prodigy Blood Glucose Test System.
| Device ID | K060467 |
| 510k Number | K060467 |
| Device Name: | PRODIGY BLOOD GLUCOSE TEST SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | DIAGNOSTIC DEVICES, INC. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm DIAGNOSTIC DEVICES, INC. PO BOX 7007 Deerfield, IL 60015 |
| 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 | 2006-02-23 |
| Decision Date | 2006-07-13 |
| Summary: | summary |