The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Truetrack Smart System Blood Glucose Meter And True Track Smart System Blood Glucose Test Strips.
Device ID | K030703 |
510k Number | K030703 |
Device Name: | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-06 |
Decision Date | 2003-07-11 |