Sysmex America, Inc. - FDA 510(k) Cleared Devices
30
Total
30
Cleared
0
Denied
FDA 510(k) cleared devices by Sysmex America, Inc. Hematology ✕
25 devices
Cleared
Jun 25, 2025
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
Hematology
89d
Cleared
Jun 25, 2025
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
Hematology
54d
Cleared
Jun 02, 2025
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
Hematology
63d
Cleared
Dec 21, 2023
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
Hematology
265d
Cleared
Nov 08, 2022
Sysmex XW-100 Automated Hematology Analyzer
Hematology
638d
Cleared
Jan 25, 2019
Sysmex XN-L Automated Hematology Analyzer
Hematology
143d
Cleared
Oct 30, 2018
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
Hematology
90d
Cleared
Apr 23, 2018
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
Hematology
304d
Cleared
Nov 06, 2017
XW-100 Automated Hematology Analyzer for CLIA Waived Use
Hematology
68d
Cleared
Dec 22, 2016
Sysmex XN-L Automated Hematology Analyzer
Hematology
300d
Cleared
Oct 12, 2015
XW-100 Automated Hematology Analyzer, XW QC CHECK
Hematology
299d
Cleared
Dec 05, 2014
SYSMEX XN SERIES
Hematology
165d
Cleared
Oct 19, 2012
SYSMEX XN-SERIES
Hematology
408d
Cleared
Mar 30, 2010
SYSMEX MODEL XT-4000I
Hematology
330d
Cleared
Oct 10, 2008
SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
Hematology
100d
Cleared
Aug 29, 2008
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
Hematology
81d
Cleared
Nov 20, 2007
SYSMEX XE-5000
Hematology
127d
Cleared
Jul 06, 2006
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
Hematology
72d
Cleared
May 10, 2006
SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
Hematology
58d
Cleared
Sep 23, 2005
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
Hematology
113d
Cleared
Aug 08, 2005
IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100...
Hematology
90d
Cleared
May 04, 2005
RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
Hematology
57d
Cleared
Mar 18, 2004
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
Hematology
64d
Cleared
Feb 11, 2004
SYSMEX POCH-100I
Hematology
166d
Cleared
Sep 08, 2003
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED...
Hematology
69d