Home Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K090495	TRUEBALANCE BLOOD GLUCOSE SYSTEM	NBW	2009-03-27	View
510(k)	K080641	TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81	NBW	2008-08-19	View
510(k)	K080710	TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81	NBW	2008-08-13	View
510(k)	K070593	TRACKRECORD DATA MANAGEMENT SOFTWARE	NBW	2007-05-07	View
510(k)	K060793	ELEMENT BLOOD GLUCOSE TEST SYSTEM	NBW	2006-07-25	View
510(k)	K051147	SIDEKICK BLOOD GLUCOSE TEST SYSTEM	NBW	2005-07-12	View
510(k)	K042080	TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM	JJX	2004-08-19	View
510(k)	K040670	MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL	NBW	2004-03-25	View
510(k)	K032657	TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)	NBW	2004-03-24	View
510(k)	K030703	TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS	NBW	2003-07-11	View
510(k)	K010403	PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700	NBW	2001-03-26	View
510(k)	K992988	PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM	CGA	1999-09-24	View
510(k)	K960855	PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL	CGA	1996-11-07	View
510(k)	K922137	DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP	CGA	1993-08-10	View
510(k)	K922136	ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP	CGA	1993-08-10	View
510(k)	K915772	DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP	CGA	1992-04-14	View
510(k)	K915770	ULTRA+ BLOOD GLUCOSE TEST STRIP	CGA	1992-04-14	View
510(k)	K912440	ULTRA BLOOD GLUCOSE MONITORING SYSTEM	CGA	1991-07-17	View
510(k)	K872505	DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS	CGA	1987-10-20	View
510(k)	K861265	DIALET LANCING DEVICE	FMK	1986-04-30	View