FDA 510(k) Applications Submitted by THOMAS M TSAKERIS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080057 |
01/09/2008 |
IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL |
NOVX SYSTEMS INC. |
| K063699 |
12/13/2006 |
IMDX SYSTEMS |
NOVX SYSTEMS INC. |
| K050132 |
01/21/2005 |
NEURO II-S |
INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. |
| K050755 |
03/23/2005 |
MODIFICATION TO BVBLUE |
GRYPHUS DIAGNOSTICS, LLC |
| K071099 |
04/19/2007 |
NEURO II-SE, MODELS: OR-DR-OR, OR-MB |
IMRIS, INC. |
| K091166 |
04/22/2009 |
IMRX |
IMRIS, INC. |
| K001687 |
06/01/2000 |
COLORMATE TLC BILITEST SYSTEM |
CHROMATICS COLOR SCIENCES INTL., INC. |
| K041635 |
06/16/2004 |
G5 I HBA1C TEST, G5 II HBA1C TEST |
PROVALIS DIAGNOSTICS LTD. |
| K011933 |
06/20/2001 |
GLYCOSAL II HBA 1C TEST |
PROVALIS DIAGNOSTICS LTD. |
| K071737 |
06/26/2007 |
GENERAL SEMEN ANALYSIS KIT |
DYN-BIOSHAF (2006) LTD. |
| K101813 |
06/29/2010 |
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO |
IMRIS, INC. |
| K061916 |
07/06/2006 |
NEURO II-SE, MODELS OR-MB-DR AND OR-DR |
IMRIS, INC. |
| K972676 |
07/16/1997 |
URINE SCREENING DEVICE |
COMBACT DIAGNOSTIC SYSTEMS LTD. |
| K062092 |
07/24/2006 |
PREVU POINT OF CARE SKIN STEROL TEST |
PREMD, INC. |
| K083137 |
10/23/2008 |
NEURO III-SV |
IMRIS, INC. |
| K993732 |
11/04/1999 |
BVBLUE |
GRYPHUS DIAGNOSTICS, L.L.C. |
| K014018 |
12/06/2001 |
CHOLESTEROL 1, 2, 3 |
IMI |
|
|
