FDA.report

510(k) K250965

Device
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
Applicant
Sysmex America, Inc.
510(k) number
K250965
Product code
JPA
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-02
Date received
2025-03-31
Regulation
864.5425
Classification name
System, Multipurpose For In Vitro Coagulation Studies
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Esther John-Olotu
Address
577 Aptakisic Rd. Lincolnshire IL US 60069 60069

FDA Registration Numbers

Source Documents

510(k) summary PDF

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