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Sysmex America, Inc. FDA Approvals
0 new drug approvals and 6 device clearances on file. Matched by name to SSMXF.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| XR-Series (XR-10, XR-20) Automated Hematology Analyzers510(k)May 27, 2026Hematology |
| Sysmex XR-Series (XR-10) Automated Hematology Analyzer510(k)Jun 25, 2025Hematology |
| Sysmex XR-Series (XR-20) Automated Hematology Analyzer510(k)Jun 25, 2025Hematology |
| Automated Blood Coagulation Analyzer CN-Series (CN-6000)510(k)Jun 2, 2025Hematology |
| Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer510(k)Dec 21, 2023Hematology |
| Sysmex XW-100 Automated Hematology Analyzer510(k)Nov 8, 2022Hematology |