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FDA 510(k) Application Details - K221460
Device Classification Name
More FDA Info for this Device
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 US
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Contact
Cynthia Phillips
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QQX
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More FDA Info for this Product Code
Date Received
05/19/2022
Decision Date
07/25/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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