The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Prestige Lx Blood Glucose Test System.
| Device ID | K992988 |
| 510k Number | K992988 |
| Device Name: | PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | HOME DIAGNOSTICS, INC. 24OO N.W. 55TH CT. Fort Lauderdale, FL 33309 |
| Contact | Karen Devincent |
| Correspondent | Karen Devincent HOME DIAGNOSTICS, INC. 24OO N.W. 55TH CT. Fort Lauderdale, FL 33309 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-03 |
| Decision Date | 1999-09-24 |