Home Diagnostics, Inc. is one of 5511 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
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
Cleared
Nov 07, 1996
PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH...
Chemistry
251d
Cleared
Aug 10, 1993
ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP
Chemistry
475d
Cleared
Aug 10, 1993
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
Chemistry
475d
Cleared
Apr 14, 1992
ULTRA+ BLOOD GLUCOSE TEST STRIP
Chemistry
112d
Cleared
Apr 14, 1992
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
Chemistry
112d
Cleared
Jul 17, 1991
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
44d
Cleared
Oct 20, 1987
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS
Chemistry
118d
Cleared
Apr 30, 1986
DIALET LANCING DEVICE
General & Plastic Surgery
26d
Cleared
Sep 16, 1985
DIASCAN CONTROL
Chemistry
21d
Cleared
Aug 06, 1985
DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS
Chemistry
110d