FibriCheck
K-Number: K173872 · 2018-09-28
ApplicantQompium NV
Decision Date2018-09-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FibriCheck is a medical device manufactured by Qompium NV. It received FDA 510(k) clearance on 2018-09-28 under approval 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. It is manufactured by Qompium NV. The 510(k) number is K173872.
When was FibriCheck approved by the FDA?
FibriCheck received FDA 510(k) clearance on 2018-09-28, under approval number K173872.
What company makes FibriCheck?
FibriCheck is manufactured by Qompium NV.
What is the FDA product code for FibriCheck?
The FDA product code for FibriCheck is DXH. This falls under the Hematology category.
Other Devices by Qompium NV
Related Devices (Code: DXH)
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.