The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Trackrecord Data Management Software.
Device ID | K070593 |
510k Number | K070593 |
Device Name: | TRACKRECORD DATA MANAGEMENT SOFTWARE |
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 | 2007-03-02 |
Decision Date | 2007-05-07 |
Summary: | summary |