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510(k) K220870

Device
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit For The BioFire Global Fever Panel
Applicant
BioFire Defense, LLC
510(k) number
K220870
Product code
QMV  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-20
Date received
2022-03-25
Regulation
866.3966
Classification name
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cynthia Pillips
Address
79 W 4500 S Suite 14 Salt Lake City UT US 84107 84107

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QMV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243463BIOFIRE FILMARRAY Tropical Fever PanelBiofire Diagnostics, LLC (Biomerieux)2024-12-05
DEN200043FilmArray Global Fever PanelBiofire Defense, LLC2020-11-20

Legacy Summary#

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FDA Review#

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