Automated Blood Coagulation Analyzer CN-Series (CN-6000)— 510(k) K250965
Substantially EquivalentSysmex America, Inc.
FDA 510(k) clearance K250965 for Automated Blood Coagulation Analyzer CN-Series (CN-6000), Substantially Equivalent on 2025-06-02. Applicant: Sysmex America, Inc.. Device class: 2.
Clearance details
- Applicant
- Sysmex America, Inc.
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincolnshire, IL, US
Recent devices under product code JPA
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view all- K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers
- K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer
- K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer
- K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
- K210346 — Sysmex XW-100 Automated Hematology Analyzer
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.