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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biotricity, Inc.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) 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. The listed applicant is Biotricity, Inc.. The 510(k) number is K172311.

When did BioFlux Device receive FDA 510(k) clearance?

BioFlux Device received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172311.

Who is the listed applicant for BioFlux Device?

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

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 records listing Biotricity, Inc. 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.

K222017BiotresK211709BiotresK201040Bioflux Software IIK162571Bioflux Software

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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