FDA 510(k) Applications Submitted by NINA GAMPERLING
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040073 |
01/14/2004 |
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) |
SYSMEX AMERICA, INC. |
| K020496 |
02/14/2002 |
HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY |
SYSMEX CORPORATION OF AMERICA |
| K050589 |
03/08/2005 |
RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
| K060656 |
03/13/2006 |
SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES |
SYSMEX AMERICA, INC. |
| K961054 |
03/18/1996 |
SYSMEX UF-100 |
SYSMEX CORP. |
| K080887 |
03/31/2008 |
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE |
SYSMEX AMERICA, INC. |
| K061150 |
04/25/2006 |
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES |
SYSMEX AMERICA, INC. |
| K981761 |
05/19/1998 |
SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX CORP. |
| K001683 |
06/01/2000 |
SYSMEX R-500 |
SYSMEX CORPORATION OF AMERICA |
| K051459 |
06/02/2005 |
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
| K081610 |
06/09/2008 |
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
| K992875 |
08/26/1999 |
SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER |
SYSMEX CORP. |
| K083002 |
10/08/2008 |
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER |
SYSMEX AMERICA, INC. |
| K053135 |
11/08/2005 |
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER |
SYSMEX AMERICA, INC. |
| K070910 |
04/02/2007 |
SYSMEX MODEL UF1000I |
SYSMEX AMERICA, INC. |
| K051199 |
05/10/2005 |
IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
| K032039 |
07/01/2003 |
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
| K071967 |
07/16/2007 |
SYSMEX XE-5000 |
SYSMEX AMERICA, INC. |
| K021241 |
04/19/2002 |
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I |
SYSMEX CORPORATION OF AMERICA |
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