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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 the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2025-06-02 under 510(k) 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. The listed applicant is Sysmex America, Inc.. The 510(k) number is K250965.

When did Automated Blood Coagulation Analyzer CN-Series (CN-6000) receive FDA 510(k) clearance?

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

Who is the listed applicant for Automated Blood Coagulation Analyzer CN-Series (CN-6000)?

The FDA 510(k) record lists Sysmex America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Sysmex America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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