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FDA 510(k) Applications for Medical Device Product Code "QVR"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K213362
BioFire Defense, LLC
BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
03/22/2023
K231336
T2 Biosystems, Inc.
T2 Biothreat Panel
09/15/2023
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