FDA 510(k) Applications Submitted by Sysmex America, Inc.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K081890 |
07/02/2008 |
SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER |
SYSMEX AMERICA, INC. |
K032677 |
08/29/2003 |
SYSMEX POCH-100I |
SYSMEX AMERICA, INC. |
K182062 |
08/01/2018 |
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device |
Sysmex America, Inc. |
K172604 |
08/30/2017 |
XW-100 Automated Hematology Analyzer for CLIA Waived Use |
Sysmex America, Inc. |
K160541 |
02/26/2016 |
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control |
SYSMEX AMERICA, INC. |
K040073 |
01/14/2004 |
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) |
SYSMEX AMERICA, INC. |
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. |
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. |
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. |
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. |
K143577 |
12/17/2014 |
XW-100 Automated Hematology Analyzer, XW QC CHECK |
SYSMEX AMERICA, INC. |
K210346 |
02/08/2021 |
Sysmex XW-100 Automated Hematology Analyzer |
Sysmex America, INC. |
K160538 |
02/26/2016 |
Sysmex XN-L Automated Hematology Analyzer |
SYSMEX AMERICA, INC. |
K091313 |
05/04/2009 |
SYSMEX MODEL XT-4000I |
SYSMEX AMERICA, INC. |
K141681 |
06/23/2014 |
SYSMEX XN SERIES |
SYSMEX AMERICA, INC. |
K171883 |
06/23/2017 |
Sysmex UF-5000 Fully Automated Urine Particle Analyzer |
Sysmex America, Inc. |
K182389 |
09/04/2018 |
Sysmex XN-L Automated Hematology Analyzer |
Sysmex America, Inc. |
K112605 |
09/07/2011 |
SYSMEX XN-SERIES |
SYSMEX AMERICA, INC. |
|
|