Home Diagnostics, Inc.

Medical device manufacturer in Fort Lauderdale, FL.

22510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K090495Truebalance Blood Glucose SystemNBW · Special 03/27/2009SE
K080641Trueresult Blood Glucose System E4H01-81NBW · Traditional 08/19/2008SE
K080710TRUE2GO Blood Glucose System, Model F4H01-81NBW · Traditional 08/13/2008SE
K070593Trackrecord Data Management SoftwareNBW · Traditional 05/07/2007SE
K060793Element Blood Glucose Test SystemNBW · Special 07/25/2006SE
K051147Sidekick Blood Glucose Test SystemNBW · Special 07/12/2005SE
K042080Trackease Smart System Blood Glucose SystemJJX · Special 08/19/2004SE
K040670Modification to Truetrack Smart System Blood Glucose Meter, Test Strips and Glucose…NBW · Special 03/25/2004SE
K032657Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose…NBW · Traditional 03/24/2004SE
K030703Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose…NBW · Traditional 07/11/2003SE
K010403Prestige Iq Blood Glucose Test System, Model 507400, 537600, 550600, 561700, 563700NBW · Special 03/26/2001SE
K992988Prestige LX Blood Glucose Test SystemCGA · Special 09/24/1999SE
K960855Prestige Blood Glucose Monitoring System,Meter,Test Strips & Prestige High and Low…CGA · Traditional 11/07/1996SE
K922137Diascan Blood Glucose Monitoring Test StripCGA · Traditional 08/10/1993SE
K922136Ultra+ Blood Glucose Monitoring Test StripCGA · Traditional 08/10/1993SE
K915772Diascan Blood Glucose Monitoring Test StripCGA · Traditional 04/14/1992SE
K915770Ultra+ Blood Glucose Test StripCGA · Traditional 04/14/1992SE
K912440Ultra Blood Glucose Monitoring SystemCGA · Traditional 07/17/1991SE
K872505Diascan* Blood Glucose Self-Monitoring Test StripsCGA · Traditional 10/20/1987SE
K861265Dialet Lancing DeviceFMK · Traditional 04/30/1986SE
K853553Diascan ControlJJX · Traditional 09/16/1985SE
K851618Diascan Blood Glucose Self-Monitor Test StripsCGA · Traditional 08/06/1985SE