Sysmex Corporation
Kobe, JP
SYSMEX CORPORATION appears in FDA device records in Kobe, JP. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Sysmex Corporation between 1979 and 2001. The busiest year on record is 1979, with 5. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 5 |
| 1995 | 5 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 1 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012372 | SYSMEX UF-50 | LKM | Substantially Equivalent | |
| K992875 | SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K981950 | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 | GKL | Substantially Equivalent | |
| K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | GKL | Substantially Equivalent | |
| K971736 | SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER | GKZ | Substantially Equivalent | |
| K964946 | SYSMEX CA-1000/SYSMEX CA-5000 | JPA | Substantially Equivalent | |
| K964375 | SYSMEX SE/RAM-1 | GKL | Substantially Equivalent | |
| K961054 | SYSMEX UF-100 | LKM | Substantially Equivalent | |
| K950508 | SYSMEX SF-3000 | FPK | Substantially Equivalent | |
| K945837 | SYSMEX(TM) F-820, 520 | GKZ | Substantially Equivalent | |
| K942097 | TOA MEDICAL ELECTRONICS CA-5000 | JPA | Substantially Equivalent | |
| K942096 | TOA MEDICAL ELECTRONICS CA-1000 | JPA | Substantially Equivalent | |
| K943894 | SYSMEX K-4500 | GKZ | Substantially Equivalent | |
| K790029 | FLUID, RHEMOX W LYSING | GGK | Substantially Equivalent | |
| K790028 | DILUENT, CELLENT BLOOD | GIF | Substantially Equivalent | |
| K790030 | FLUID, RHEMOX-HB LYSING | GKR | Substantially Equivalent | |
| K790027 | SHAKER, MODEL SH-510 | JRQ | Substantially Equivalent | |
| K790026 | ANALYZER, MODEL CC-720 | GKL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010421384 | 3010421384 | SYSMEX CORPORATION | 4-4-4 TAKATSUKADAI NISHI-KU, KOBE Hyogo 651-2271 JP | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
- JITCalibrator, Secondary
- JIWCalibrator, Surrogate
- NNIContainer, Specimen, Non-Sterile
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- LKMCounter, Urine Particle
- JOYDevice, Automated Cell-Locating
- GIFDiluent, Blood Cell
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- GKPInstrument, Coagulation, Automated
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- GGKProducts, Red-Cell Lysing Products
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- JRQShaker/Stirrer
- KPASlide Stainer, Automated
- GJHStain, Reticulocyte
- KQCStains, Hematology
- GKRSystem, Hemoglobin, Automated
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- FPKTubing, Fluid Delivery
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1945-2016 | The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. | There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain