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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 K221460
Device Name BioFire COVID-19 Test 2
BioFire Defense, LLC
79 W 4500 S, Suite 14
Salt Lake City,  UT  84107
Applicant Contact Cynthia Phillips
BioFire Defence, LLC
79 W 4500 S, Suite 14
Salt Lake City,  UT  84107
Correspondent Contact Cynthia Phillips
Regulation Number866.3981
Classification Product Code
Date Received05/19/2022
Decision Date 07/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No