Is this your brand? Sign in to claim ownership.
Sign in to claim this brandInformation
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (112)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sysmex Xe-2100, Automatated Hematology Analyzer | K992875 | FDA 510(k) | Class II | Active |
| Sysmex Se/Ram-1 | K964375 | FDA 510(k) | Class II | Active |
| Diluent, Cellent Blood | K790028 | FDA 510(k) | Class I | Active |
| Shaker, Model Sh-510 | K790027 | FDA 510(k) | Class I | Active |
| Fluid, Rhemox-Hb Lysing | K790030 | FDA 510(k) | Class II | Active |
| Fluid, Rhemox W Lysing | K790029 | FDA 510(k) | Class I | Active |
| Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500 | K981950 | FDA 510(k) | Class II | Active |
| Toa Medical Electronics Ca-5000 | K942097 | FDA 510(k) | Class II | Active |
| Sysmex K-4500 | K943894 | FDA 510(k) | Class II | Active |
| Sysmex Uf-100 | K961054 | FDA 510(k) | Class II | Active |
| Sysmex Sf-3000 | K950508 | FDA 510(k) | Class II | Active |
| Sysmex Kx-21, Automated Hematology Analyzer | K981761 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.