BioFlux Device
K-Number: K172311 · 2017-12-15
ApplicantBiotricity, Inc.
Decision Date2017-12-15
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
BioFlux Device is a medical device manufactured by Biotricity, Inc.. It received FDA 510(k) clearance on 2017-12-15 under approval number K172311. 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 BioFlux Device?
BioFlux Device is a medical device that received FDA 510(k) clearance on 2017-12-15. It is manufactured by Biotricity, Inc.. The 510(k) number is K172311.
When was BioFlux Device approved by the FDA?
BioFlux Device received FDA 510(k) clearance on 2017-12-15, under approval number K172311.
What company makes BioFlux Device?
BioFlux Device is manufactured by Biotricity, Inc..
What is the FDA product code for BioFlux Device?
The FDA product code for BioFlux Device is DXH. This falls under the Hematology category.
Other Devices by Biotricity, Inc.
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.