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510(k) K173202

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set by Sekisui Medical Co., Ltd. — Product Code JPA

K173202 is an FDA 510(k) premarket notification submitted by Sekisui Medical Co., Ltd. for the device "CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set". The FDA issued a decision of Substantially Equivalent on May 9, 2018. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2018
Date Received
October 2, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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FDA data resources