The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Trackease Smart System Blood Glucose System.
| Device ID | K042080 |
| 510k Number | K042080 |
| Device Name: | TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | HOME DIAGNOSTICS, INC. 2400 N.W. 55TH CT. Fort Lauderdale, FL 33309 |
| Contact | Karen Devincent |
| Correspondent | Karen Devincent HOME DIAGNOSTICS, INC. 2400 N.W. 55TH CT. Fort Lauderdale, FL 33309 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-03 |
| Decision Date | 2004-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10087701403511 | K042080 | 000 |