Data / Medical devices / Japan / Sysmex Corporation Kakogawa Factory
Sysmex Corporation Kakogawa Factory: FDA-registered device maker in Kakogawa Hyogo, Japan, 8 510(k) clearances
Sysmex Corporation Kakogawa Factory is registered with the FDA (registration 3002759288) in Kakogawa Hyogo, Japan. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 21, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002759288
- Address
- 314-2 Kitano, Noguchi-cho, Kakogawa Hyogo, Japan, 675-0011
- Owner or operator
- SYSMEX CORPORATION (9014170)
- Roles
- Manufacturer
- First device listed
- May 21, 2008
- Registered through
- 2027
- Brand names listed
- AUTOMATED HEMATOLOGY ANALYZER XW-100, AlphaN-SPSU, AlphaN-XESU, BT-50, Barcode Terminal (BT-40), CA-7000, CF-60, CF-70 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Counter, Cell, Automated (Particle Counter) | GKL | 2 | Manufacturer | accessdata.fda.gov |
| Counter, Differential Cell | GKZ | 2 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Coagulation, Automated | GKP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2023 | K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| November 8, 2022 | K210346 | Sysmex XW-100 Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| January 25, 2019 | K182389 | Sysmex XN-L Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| November 6, 2017 | K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| December 22, 2016 | K160538 | Sysmex XN-L Automated Hematology Analyzer | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| February 11, 2004 | K032677 | SYSMEX POCH-100I | GKL | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| June 27, 2002 | K020979 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 | GKP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 14, 1998 | K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | GKL | Substantially Equivalent | Sysmex Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Counter, Differential Cell
- All makers of Counter, Cell, Automated (Particle Counter)
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Instrument, Coagulation, Automated
Updated December 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.