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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory specimen nucleic acid sars-cov-2 test
510(k) Number K211079
Device Name BioFire COVID-19 Test 2
Applicant
BioFire Defense, LLC
79 W 4500 S, Suite 14
salt lake city,  UT  84107
Applicant Contact cynthia phillips
Correspondent
BioFire Defense, LLC
79 W 4500 S, Suite 14
salt lake city,  UT  84107
Correspondent Contact cynthia phillips
Regulation Number866.3981
Classification Product Code
QQX  
Date Received04/12/2021
Decision Date 11/01/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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