The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Element Blood Glucose Test System.
| Device ID | K060793 |
| 510k Number | K060793 |
| Device Name: | ELEMENT BLOOD GLUCOSE TEST SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | HOME DIAGNOSTICS, INC. 2400 N.W. 55TH CT. Fort Lauderdale, FL 33309 |
| Contact | Karen De Vincent |
| Correspondent | Karen De Vincent HOME DIAGNOSTICS, INC. 2400 N.W. 55TH CT. Fort Lauderdale, FL 33309 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-23 |
| Decision Date | 2006-07-25 |