Sysmex America, Inc.
FDA 510(k) medical device clearances.
Top product codes for Sysmex America, Inc.
Recent clearances by Sysmex America, Inc.
- K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer
- K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer
- K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
- K210346 — Sysmex XW-100 Automated Hematology Analyzer
- K182389 — Sysmex XN-L Automated Hematology Analyzer
- K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
- K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer
- K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use
- K160538 — Sysmex XN-L Automated Hematology Analyzer
- K160541 — Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
- K143577 — XW-100 Automated Hematology Analyzer, XW QC CHECK
- K141681 — SYSMEX XN SERIES
- K112605 — SYSMEX XN-SERIES
- K091313 — SYSMEX MODEL XT-4000I
- K083002 — SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
- K081890 — SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
- K081610 — SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
- K080887 — SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
- K071967 — SYSMEX XE-5000
- K070910 — SYSMEX MODEL UF1000I
- K061150 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
- K060656 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
- K053135 — SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
- K051459 — SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
- K051199 — IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K050589 — RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K040073 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
- K032677 — SYSMEX POCH-100I
- K032039 — IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.