Data / Medical devices / Japan / Sysmex RA Co., LTD, Main Office
Sysmex RA Co., LTD, Main Office: FDA-registered device maker in Shiojiri Nagano, Japan, 1 510(k) clearance
Sysmex RA Co., LTD, Main Office is registered with the FDA (registration 3010188766) in Shiojiri Nagano, Japan. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 8, 2003. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3010188766
- Address
- 3034 Hirooka-Nomura, Shiojiri Nagano, Japan, 399-0702
- Owner or operator
- SYSMEX CORPORATION (9014170)
- Roles
- Manufacturer
- First device listed
- July 6, 2011
- Registered through
- 2027
- Brand names listed
- AUW TRACK, AlphaN-SPSU, AlphaN-XESU, BT-50, Barcode Terminal (BT-40), CA-620, CA-660, CF-60 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | 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 |
| Slide Stainer, Automated | KPA | 1 | Manufacturer | accessdata.fda.gov |
| Timer, General Laboratory | JBS | 1 | 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 |
|---|---|---|---|---|---|---|
| September 8, 2003 | K031377 | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 | GKP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Slide Stainer, Automated
- All makers of Instrument, Coagulation, Automated
- All makers of Timer, General Laboratory
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Updated September 8, 2003. 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.