The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for True2go Blood Glucose System, Model F4h01-81.
Device ID | K080710 |
510k Number | K080710 |
Device Name: | TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 |
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 | 2008-03-13 |
Decision Date | 2008-08-13 |