SYSMEX AMERICA, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1422681	1000515253	SYSMEX AMERICA, INC.	1	N	2026-01-01	ONE SYSMEX WAY Mundelein IL US 60060
3009495621	3009495621	Sysmex America, Inc.	1	Y	2026-01-01	SAI - Multi-Purpose Building 1701 Leider Lane Buffalo Grove IL US 60089
3009711478	3009711478	Sysmex America, Inc.	1	Y	2026-01-01	577 Aptakisic Rd Lincolnshire IL US 60069

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00664369000639	Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software - Fully Automated Urine Cell Analyzer UF-1000i UF WAM	+1(888)879-7639	crc@sysmex.com
00664369000752	WAM (Work Area Management) - 5.X	+1(888)879-7644	crc@sysmex.com
00664369000851	Caresphere Workflow Solution - 1.X	+1(888)879-7639	crc@sysmex.com

sysmex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
143607	1110426848	K994388	XE CHECK	GLQ	2000-01-14
138827	1848643651	K992875	SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER	GKZ	1999-11-09
143607	1848643651	K992875	SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER	GKZ	1999-11-09
143607	1719082701	K981761	SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER	GKL	1998-08-14
138827	1719082701	K981761	SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER	GKL	1998-08-14
143607	1246812611	K960557	CALIBRATION VERIFICATION ASSESSMENT (CVA)	JPK	1996-04-03
143607	1832978632	K943268	SCS-1000 (SYSMEX CALIBRATOR SYSTEM)	KSA	1994-12-15
143607	1537054745	K852992	PARA CHECK (AKA EIGHT CHECK-C)	JPK	1985-10-10
143607	1885855762	K251371	Sysmex XR-Series (XR-20) Automated Hematology Analyzer	GKZ	2025-06-25
138827	1885855762	K251371	Sysmex XR-Series (XR-20) Automated Hematology Analyzer	GKZ	2025-06-25
143607	1803774242	K250965	Automated Blood Coagulation Analyzer CN-Series (CN-6000)	JPA	2025-06-02
143607	1609244247	K250943	Sysmex XR-Series (XR-10) Automated Hematology Analyzer	GKZ	2025-06-25
138827	1609244247	K250943	Sysmex XR-Series (XR-10) Automated Hematology Analyzer	GKZ	2025-06-25
143607	1385701676	K230887	Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer	GKZ	2023-12-21
138827	1385701676	K230887	Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer	GKZ	2023-12-21
143607	1045364414	K210346	Sysmex XW-100 Automated Hematology Analyzer	GKZ	2022-11-08
138827	1045364414	K210346	Sysmex XW-100 Automated Hematology Analyzer	GKZ	2022-11-08
143607	1212912019	K182389	Sysmex XN-L Automated Hematology Analyzer	GKZ	2019-01-25
143607	1859007873	K182062	Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device	JOY	2018-10-30
138827	1859007873	K182062	Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device	JOY	2018-10-30
143607	2048654619	K172604	XW-100 Automated Hematology Analyzer for CLIA Waived Use	GKZ	2017-11-06
138827	2048654619	K172604	XW-100 Automated Hematology Analyzer for CLIA Waived Use	GKZ	2017-11-06
138827	1777403764	K171883	Sysmex UF-5000 Fully Automated Urine Particle Analyzer	LKM	2018-04-23
143607	1777403764	K171883	Sysmex UF-5000 Fully Automated Urine Particle Analyzer	LKM	2018-04-23
143607	1503827362	K160590	XN CHECK	JPK	2016-12-22
143607	1487195799	K160586	XN-L CHECK	JPK	2016-12-22
143607	1944308338	K160541	Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control	JLW	2016-10-21
143607	1388762502	K160538	Sysmex XN-L Automated Hematology Analyzer	GKZ	2016-12-22
138827	1388762502	K160538	Sysmex XN-L Automated Hematology Analyzer	GKZ	2016-12-22
143607	1070718612	K151259	Sysmex Automated Blood Coagulation Analyzer CS-2100i	JPA	2016-01-26
138827	1070718612	K151259	Sysmex Automated Blood Coagulation Analyzer CS-2100i	JPA	2016-01-26
143607	1094432815	K150678	Sysmex Automated Blood Coagulation Analyzer CS-5100	JPA	2016-01-11
138827	1094432815	K150678	Sysmex Automated Blood Coagulation Analyzer CS-5100	JPA	2016-01-11
143607	2035153227	K143577	XW-100 Automated Hematology Analyzer, XW QC CHECK	GKZ	2015-10-12
138827	1880702706	K141681	SYSMEX XN SERIES	GKZ	2014-12-05
143607	1880702706	K141681	SYSMEX XN SERIES	GKZ	2014-12-05
143607	2034466862	K120747	XN CAL PF	KRX	2012-10-22
143607	1824919607	K120745	XN CAL	KRX	2012-10-19
143607	1400786079	K120744	XN CHECK BF	JPK	2012-10-19
143607	2069195732	K120742	XN CHECK	JPK	2012-10-19
138827	1130760210	K112605	SYSMEX XN-SERIES	GKZ	2012-10-19
143607	1130760210	K112605	SYSMEX XN-SERIES	GKZ	2012-10-19
143607	1421244356	K091313	SYSMEX MODEL XT-4000I	GKZ	2010-03-30
143607	1582735243	K083200	X-CAL	KRX	2009-02-03
143607	1723249235	K081610	SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER	GKZ	2008-08-29
143607	1537825231	K080887	SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE	LKM	2008-05-02
143607	1522702637	K070910	SYSMEX MODEL UF1000I	LKM	2007-05-25
143607	2017120963	K063218	E-CHECK (XE)	JPK	2006-12-14
143607	1560510851	K060656	SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES	GKZ	2006-05-10
138827	1287093300	K051459	SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER	GKZ	2005-09-23
143607	1287093300	K051459	SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER	GKZ	2005-09-23
143607	1810622695	K032677	SYSMEX POCH-100I	GKL	2004-02-11
138827	1810622695	K032677	SYSMEX POCH-100I	GKL	2004-02-11
143607	1131324119	K031377	SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560	GKP	2003-09-08
138827	1131324119	K031377	SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560	GKP	2003-09-08
143607	1652547753	K011235	SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500	JPA	2001-07-20
143607	1038840409	BK210631
143607	1434545022	BK210559
138827	1434545022	BK210559
138827	1079165511
138827	1254725906
138827	1783397844
143607	1013929014
143607	1079165511
143607	1109337806
138827	1181515875
143607	1181515875
143607	1254725906
143607	1344661002
143607	1495880228
138827	1496186002
143607	1536407795
143607	1568343799
143607	1580211431
143607	1624318494
143607	1676958898
143607	1717531210
15586	1717531210
138827	1758880759
143607	1783397844
143607	1869608402
143607	1934960437
138827	1934960437
143607	2012481180
138827	2067379409

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GKZ	27	2025-06-25
JPK	7	2016-12-22
JPA	6	2025-06-02
LKM	4	2018-04-23
GKL	4	2004-02-11
KRX	3	2012-10-22
JOY	2	2018-10-30
GKP	2	2003-09-08
JLW	1	2016-10-21
GLQ	1	2000-01-14
KSA	1	1994-12-15

PMN#

Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
2023-12-21
Sysmex America, Inc.
Sysmex XW-100 Automated Hematology Analyzer
2022-11-08
Sysmex America, Inc.
Counter, Differential Cell
2021-05-27
Sysmex America, Inc.
Sysmex XN-L Automated Hematology Analyzer
2019-01-25
Sysmex America, Inc.
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
2018-10-30
Sysmex America, Inc.
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
2018-04-23
Sysmex America, Inc.
XW-100 Automated Hematology Analyzer For CLIA Waived Use
2017-11-06
Sysmex America, Inc.
Sysmex XN-L Automated Hematology Analyzer
2016-12-22
SYSMEX AMERICA, INC.
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
2016-10-21
SYSMEX AMERICA, INC.
XW-100 Automated Hematology Analyzer, XW QC CHECK
2015-10-12
SYSMEX AMERICA, INC.
SYSMEX XN SERIES
2014-12-05
SYSMEX AMERICA, INC.
SYSMEX XN-SERIES
2012-10-19
SYSMEX AMERICA, INC.
SYSMEX MODEL XT-4000I
2010-03-30
SYSMEX AMERICA, INC.
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
2009-02-03
Sysmex America, Inc.
SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
2008-10-10
SYSMEX AMERICA, INC.
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
2008-08-29
SYSMEX AMERICA, INC.
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
2008-05-02
SYSMEX AMERICA, INC.
SYSMEX XE-5000
2007-11-20
SYSMEX AMERICA, INC.
SYSMEX MODEL UF1000I
2007-05-25
SYSMEX AMERICA, INC.
SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
2006-05-10
SYSMEX AMERICA, INC.
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
2006-01-04
SYSMEX AMERICA, INC.
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
2005-09-23
SYSMEX AMERICA, INC.
IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
2005-08-08
SYSMEX AMERICA, INC.
RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
2005-05-04
SYSMEX AMERICA, INC.
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
2004-03-18
SYSMEX AMERICA, INC.
SYSMEX POCH-100I
2004-02-11
SYSMEX AMERICA, INC.
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
2003-09-08
SYSMEX AMERICA, INC.

GUDID#

Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software - Fully Automated Urine Cell Analyzer UF-1000i UF WAM
Sysmex America, Inc.
2016-08-04
WAM (Work Area Management) - 5.X
Sysmex America, Inc.
2025-03-14
Caresphere Workflow Solution - 1.X
Sysmex America, Inc.
2022-12-07