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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 the device name listed in this FDA 510(k) record. The listed applicant is Sekisui Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-05-09 under 510(k) 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. The listed applicant is Sekisui Medical Co., Ltd.. The 510(k) number is K173202.

When did CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set receive FDA 510(k) clearance?

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

Who is the listed applicant for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

The FDA 510(k) record lists Sekisui Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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