The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Prestige Iq Blood Glucose Test System, Model 507400, 537600, 550600, 561700, 563700.
| Device ID | K010403 |
| 510k Number | K010403 |
| Device Name: | PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-12 |
| Decision Date | 2001-03-26 |