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FDA 510(k) Application Details - DEN220039
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN220039
Device Name
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
Applicant
Quidel Corporation
10165 McKellar Court
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Xiaoxi Wang
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QVF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2022
Decision Date
03/08/2023
Decision
DENG -
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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