Home Diagnostics, Inc. is one of 13712 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Home Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: TRUEBALANCE BLOOD GLUCOSE SYSTEM, TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81, TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
22
Total
22
Cleared
0
Denied
Home Diagnostics, Inc. has 22 FDA 510(k) cleared chemistry devices. Based in Eatontown, US.
Historical record: 22 cleared submissions from 1985 to 2009.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Home Diagnostics, Inc.
22 devices
Cleared
Mar 27, 2009
TRUEBALANCE BLOOD GLUCOSE SYSTEM
Chemistry
30d
Cleared
Aug 19, 2008
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
Chemistry
166d
Cleared
Aug 13, 2008
TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
Chemistry
153d
Cleared
May 07, 2007
TRACKRECORD DATA MANAGEMENT SOFTWARE
Chemistry
66d
Cleared
Jul 25, 2006
ELEMENT BLOOD GLUCOSE TEST SYSTEM
Chemistry
124d
Cleared
Jul 12, 2005
SIDEKICK BLOOD GLUCOSE TEST SYSTEM
Chemistry
69d
Cleared
Aug 19, 2004
TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
Chemistry
16d
Cleared
Mar 25, 2004
MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND...
Chemistry
10d
Cleared
Mar 24, 2004
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND...
Chemistry
209d
Cleared
Jul 11, 2003
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD...
Chemistry
127d
Cleared
Mar 26, 2001
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700,...
Chemistry
42d
Cleared
Sep 24, 1999
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
Chemistry
21d