The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Truebalance Blood Glucose System.
| Device ID | K090495 |
| 510k Number | K090495 |
| Device Name: | TRUEBALANCE BLOOD GLUCOSE SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00021292007959 | K090495 | 000 |
| 00021292007942 | K090495 | 000 |
| 00021292003418 | K090495 | 000 |
| 20212920031352 | K090495 | 000 |