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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
Predetermined Change
Control Plan Authorized		 No
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