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FDA 510(k)

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set

K-Number: K173202 · 2018-05-09

ApplicantSekisui Medical Co., Ltd.
Decision Date2018-05-09
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is a medical device manufactured by Sekisui Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-05-09 under approval number K173202. 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 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is a medical device that received FDA 510(k) clearance on 2018-05-09. It is manufactured by Sekisui Medical Co., Ltd.. The 510(k) number is K173202.

When was CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set approved by the FDA?

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set received FDA 510(k) clearance on 2018-05-09, under approval number K173202.

What company makes CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is manufactured by Sekisui Medical Co., Ltd..

What is the FDA product code for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

The FDA product code for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is JPA.

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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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