Automated Blood Coagulation Analyzer CN-Series (CN-6000)— 510(k) K250965

Substantially Equivalent

Sysmex 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..

Clearance details

Applicant: Sysmex America, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 2025-03-31
Decision date: 2025-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.