FDA 510(k) Applications Submitted by KAREN DE VINCENT
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K060793 |
03/23/2006 |
ELEMENT BLOOD GLUCOSE TEST SYSTEM |
HOME DIAGNOSTICS, INC. |
| K010403 |
02/12/2001 |
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 |
HOME DIAGNOSTICS, INC. |
| K090495 |
02/25/2009 |
TRUEBALANCE BLOOD GLUCOSE SYSTEM |
HOME DIAGNOSTICS, INC. |
| K070593 |
03/02/2007 |
TRACKRECORD DATA MANAGEMENT SOFTWARE |
HOME DIAGNOSTICS, INC. |
| K030703 |
03/06/2003 |
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS |
HOME DIAGNOSTICS, INC. |
| K080641 |
03/06/2008 |
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 |
HOME DIAGNOSTICS, INC. |
| K080710 |
03/13/2008 |
TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 |
HOME DIAGNOSTICS, INC. |
| K040670 |
03/15/2004 |
MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL |
HOME DIAGNOSTICS, INC. |
| K120989 |
04/02/2012 |
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM |
NIPRO DIAGNOSTICS, INC. |
| K051147 |
05/04/2005 |
SIDEKICK BLOOD GLUCOSE TEST SYSTEM |
HOME DIAGNOSTICS, INC. |
| K042080 |
08/03/2004 |
TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM |
HOME DIAGNOSTICS, INC. |
| K032657 |
08/28/2003 |
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) |
HOME DIAGNOSTICS, INC. |
| K992988 |
09/03/1999 |
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM |
HOME DIAGNOSTICS, INC. |
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