Company ยท US
Sysmex Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2001. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKZ | Counter, Differential Cell | 5 |
| GKL | Counter, Cell, Automated (Particle Counter) | 4 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 3 |
| LKM | Counter, Urine Particle | 2 |
| FPK | Tubing, Fluid Delivery | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 |
| GIF | Diluent, Blood Cell | 1 |
| GKR | System, Hemoglobin, Automated | 1 |
| JRQ | Shaker/Stirrer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 28, 2001 | K012372 | SYSMEX UF-50 Sysmex Corp. | LKM |
| Nov 9, 1999 | K992875 | SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER Sysmex Corp. | GKZ |
| Nov 3, 1998 | K981950 | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 Sysmex Corp. | GKL |
| Aug 14, 1998 | K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER Sysmex Corp. | GKL |
| Aug 26, 1997 | K971736 | SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER Sysmex Corp. | GKZ |
| Mar 18, 1997 | K964946 | SYSMEX CA-1000/SYSMEX CA-5000 Sysmex Corp. | JPA |
| Mar 13, 1997 | K964375 | SYSMEX SE/RAM-1 Sysmex Corp. | GKL |
| Oct 28, 1996 | K961054 | SYSMEX UF-100 Sysmex Corp. | LKM |
| Nov 3, 1995 | K950508 | SYSMEX SF-3000 Sysmex Corp. | FPK |
| Jun 9, 1995 | K945837 | SYSMEX(TM) F-820, 520 Sysmex Corp. | GKZ |
| Mar 24, 1995 | K942097 | TOA MEDICAL ELECTRONICS CA-5000 Sysmex Corp. | JPA |
| Mar 24, 1995 | K942096 | TOA MEDICAL ELECTRONICS CA-1000 Sysmex Corp. | JPA |
| Feb 3, 1995 | K943894 | SYSMEX K-4500 Sysmex Corp. | GKZ |
| Feb 26, 1979 | K790029 | FLUID, RHEMOX W LYSING Sysmex Corp. | GGK |
| Feb 15, 1979 | K790028 | DILUENT, CELLENT BLOOD Sysmex Corp. | GIF |
| Feb 8, 1979 | K790030 | FLUID, RHEMOX-HB LYSING Sysmex Corp. | GKR |
| Feb 8, 1979 | K790027 | SHAKER, MODEL SH-510 Sysmex Corp. | JRQ |
| Feb 8, 1979 | K790026 | ANALYZER, MODEL CC-720 Sysmex Corp. | GKL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2016 | Sysmex Corporation 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 laboratorie Terminated |
GKZ | K112605 |