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FDA 510(k)

Automated Blood Coagulation Analyzer CN-Series (CN-6000)

K-Number: K250965 · 2025-06-02

ApplicantSysmex America, Inc.
Decision Date2025-06-02
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Automated Blood Coagulation Analyzer CN-Series (CN-6000) is a medical device manufactured by Sysmex America, Inc.. It received FDA 510(k) clearance on 2025-06-02 under approval number K250965. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Automated Blood Coagulation Analyzer CN-Series (CN-6000)?

Automated Blood Coagulation Analyzer CN-Series (CN-6000) is a medical device that received FDA 510(k) clearance on 2025-06-02. It is manufactured by Sysmex America, Inc.. The 510(k) number is K250965.

When was Automated Blood Coagulation Analyzer CN-Series (CN-6000) approved by the FDA?

Automated Blood Coagulation Analyzer CN-Series (CN-6000) received FDA 510(k) clearance on 2025-06-02, under approval number K250965.

What company makes Automated Blood Coagulation Analyzer CN-Series (CN-6000)?

Automated Blood Coagulation Analyzer CN-Series (CN-6000) is manufactured by Sysmex America, Inc..

What is the FDA product code for Automated Blood Coagulation Analyzer CN-Series (CN-6000)?

The FDA product code for Automated Blood Coagulation Analyzer CN-Series (CN-6000) is JPA.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025)

Other Devices by Sysmex America, Inc.

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Related Devices (Code: JPA)

K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161312Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic Products GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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