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FDA 510(k) Application Details - DEN220028
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN220028
Device Name
Cue COVID-19 Molecular Test
Applicant
Cue Health Inc.
4980 Carroll Canyon Road Suite 100
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Roderick Castillo
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QWB
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More FDA Info for this Product Code
Date Received
05/02/2022
Decision Date
06/06/2023
Decision
DENG -
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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