Cleared Traditional

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

K250965 · Sysmex America, Inc. · Hematology
Jun 2025
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K250965 is an FDA 510(k) clearance for the Automated Blood Coagulation Analyzer CN-Series (CN-6000), a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on June 2, 2025, 63 days after receiving the submission on March 31, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K250965 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2025
Decision Date June 02, 2025
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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