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FDA 510(k)

FibriCheck

K-Number: K173872 · 2018-09-28

ApplicantQompium NV
Decision Date2018-09-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FibriCheck is the device name listed in this FDA 510(k) record. The listed applicant is Qompium NV. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K173872. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FibriCheck?

FibriCheck is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Qompium NV. The 510(k) number is K173872.

When did FibriCheck receive FDA 510(k) clearance?

FibriCheck received FDA 510(k) clearance on 2018-09-28, under 510(k) number K173872.

Who is the listed applicant for FibriCheck?

The FDA 510(k) record lists Qompium NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FibriCheck?

The FDA product code for FibriCheck is DXH. This falls under the Hematology category.

Other records listing Qompium NV as applicant

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.

K232804FibriCheck

Related Devices (Code: DXH)

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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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