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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
Applicant
Biofire Defense, LLC
79 W 4500 S
Suite 14
Salt Lake City,  UT  84107
Applicant Contact Cynthia Phillips
Correspondent
Biofire Defence, LLC
79 W 4500 S
Suite 14
Salt Lake City,  UT  84107
Correspondent Contact Cynthia Phillips
Regulation Number866.3981
Classification Product Code
QQX  
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
Predetermined Change
Control Plan Authorized		 No
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